February 1, 2015

Dear Ms. Knachal and Virginia Board of Audiology and Speech Pathology Board Members,

I am contacting you today as a member of the Illinois Board of Speech Pathology and Audiology in the hopes that you will consider my comments regarding the Virginia Emergency Regulations as they pertain to Cerumen Management by audiologists. While I commend you and your Board on the creation of much needed cerumen removal language, I believe that the language is so restrictive that it will impede quality care.

While I believe that your intention, as a consumer protection board, is to create language that will provide unparalleled protection for the consumer, the proposed language is so specific and restrictive that, it will have the unintended consequence of substantially hindering patient access to trained, competent and affordable cerumen management services.  

This reduction in access could lead patients to obtain cerumen management services from individuals, including but not limited to, nurses and medical assistants who are less trained than audiologists. Virginia’s current Regulations Governing the Practice of Audiology and Speech Pathology indicate, in section 18VAC30-20-280 (Unprofessional conduct) the following sections that would make inappropriate removal of cerumen by an audiologist an infraction of your existing licensure laws and regulations.  Those sections include, but are not limited to:

“Section 5: Incompetence or negligence in the practice of the profession;

Section 7. Failure to refer a client to an appropriate health care practitioner when there is evidence of an impairment for which assessment, evaluation, care or treatment might be necessary; and

Section 12. Inability to practice with skill and safety”. 

As a result of these existing regulations, the extent of the language in the current Emergency Regulations as they pertain to Cerumen Management by Audiologists appears unnecessarily detailed. You already have protections in place for consumers.

It should also be noted that physicians, even otolaryngologists, are not immune to medical errors in the removal of cerumen.  An article, published in October of 2013 in the Journal of Otolaryngology, Head and Neck Surgery (http://www.ncbi.nlm.nih.gov/pubmed/23894144), reported that, in the cases reviewed, cerumen removal was the most common procedure leading to malpractice claims in otolaryngology. 

If permanently enacted, Virginia would become one of the 22 states to have laws, regulations or guidelines on cerumen management by audiologists.  The American Speech Language Hearing Association (ASHA) has an excellent summary of these regulations as they exist in each of these states.  This is available at http://www.asha.org/Advocacy/state/State-Cerumen-Management-Requirements/. As you will note, outside of the regulations in California, Maryland and New Jersey, the language pertaining to cerumen removal by audiologists is very broad. This type of broad language allows for definition of scope for the audiologist, while allowing the patient the ability to receive accessible, affordable care by appropriately trained and competent audiologists. 

There is not a single audiology licensure law in this country (nor any code of ethics from any professional audiology association) that does not prohibit licensees from performing a service for which they are not appropriately trained and competent, nor does any licensure law or code of ethics permit services which will be harmful to the patient. 

I might suggest modifications to your emergency regulation that included the following;

A. In order for an audiologist to perform cerumen management, he shall:

1. Be a graduate of a doctoral program in audiology and which included didactic education and supervised clinical experience in cerumen management as specified in subsection B of this section; or

2. Complete a course or workshop in cerumen management which provides training as specified in subsection B of this section and which is approved by the American Speech-Language Hearing Association, the American Academy of Audiology, or another medical society or association.

B. An audiologist shall maintain documentation evidencing satisfactory completion of training in cerumen management to include the following:

1. Recognizing the presence of pre-existing contraindications that necessitate referral to a physician;

2. Recognizing patient distress and appropriate action to take if complications are encountered;

3. Use of infection control precautions;

4. Procedures for removal of cerumen, including cerumen loop, gentle water irrigation, suction and the use of material for softening;

C. An audiologist performing cerumen management shall:

1. Obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record.

2. Refer patients to a physician if they exhibit contraindications or experience any complication, such as dizziness, drainage, bleeding or pain, during or following the procedure.

Thank you for your consideration of my comments and for the opportunity to share my thoughts.  Please feel free to contact me at kim.cavitt@audiologyresources.com or 773-960-6625 if you have additional questions or concerns.

Respectfully,

Kim Cavitt, AuD

Vice-Chair, Illinois Board of Speech Pathology and Audiology

Adjunct Lecturer, Northwestern University

President, Audiology Resources, Inc.

Comments with regard to BOARD OF AUDIOLOGY AND SPEECH-LANGUAGE PATHOLOGY Emergency Cerumen Management Regulations:

18VAC30-20-241.A.2 Please consider adding the following text to this section:

“Completion of clinical practicum and fellowship requirements for an MA/MS (masters level) program in audiology approved by the American Speech-Language-Hearing Association shall be accepted as fulfillment of this course requirement.”

18VAC30-20-241.B Please consider adding the following text to this section:

“A University transcript showing completion of a doctoral or masters level program in audiology shall be accepted as documentation evidencing satisfactory completion of training in cerumen management.”

An optional, and very practical approach to satisfying this requirement, would be to have a letter from a physician that certifies the audiologist in terms of his or her ability to perform all that is required for safe and effective cerumen management.

18VAC30-20-241.C Comments

Some of the pre-existing contraindications listed in this section impose an unacceptable burden on patients who are home bound or who have significant mobility restrictions. I work alongside Riverside PACE and Riverside House Calls Practice to serve patients who have multiple health problems and who often have restricted mobility. Physicians from these organizations call on me to remove cerumen for people with some of the contraindications on this list. I would be able to serve nearly all of the patients referred to me for cerumen management if you eliminate the following contraindications:

 Diabetes

Stenosis or bony exostosis

 Impaction that totally occludes the ear

Inability to see at least 25% of the tympanic membrane

Cerumen management can be performed by audiologists in a safe and effective manner for patients with these conditions. I have been doing this on the Virginia peninsula for 12 years. My referrals to otolaryngologists are typically for deep-seated cerumen and dead skin occlusions that are not responsive to irrigation.

Thank you for the opportunity to provide comments on these emergency regulations.

I hold a license to practice Audiology in Virginia, however my current practice is in Maryland.  It is my opinion that the proposed new regulations regarding Cerumen Management are entirely too restrictive.  I have worked in ENT physicians offices where cerumen management is performed on a regular basis (even on children!) by technicians and medical assistants who have no where near that level of education, traininig or supervised experience with cerumen removal.  So I don't see how restricting the scope of practice for audiologists in general is going to be saving patients from having wax removed by someone who is not qualified.  Audiologists only perform the procedure if they have been trained and have the proper equipment.  It is within our scope of practice and so therefore we use our judgement to ensure the safety of the patient.  To restrict the scope of practice will only create problems for patients and make solving their hearing problems that much more complex and daunting.  There are other issues your body could be spending it's time on that would be much more benefitical than this one for sure.  Also, I'm confused as to how this could be viewed ad increasing our scope of practice when in fact it restricts it further?  I would suggest that no regulations are needed.  If you are going to regulate, then regulate who can perform the procedure period (ie untrained medical assistants or nurses in a physicians office with no education or supevised experience or formal training in it) and not JUST restrict audiologists.  

As an audiology licensee in the Commonwealth of Virginia for over thirty-six years, I commend the Board for its ongoing service to audiologists of Virginia and to the citizens of the Commonwealth that we jointly serve.  I have provided audiology services in a variety of locations across central Virginia, including academic medicine (VCU Hospitals), inpatient/outpatient rehabilitation (Sheltering Arms Hospital), ENT private practice, and most recently, my own audiology private practice.     Access to the ear canal (and professional management of all aspects of complications that interfere with that) is the cornerstone of literally everything an audiologist does professionally.  Many aspects of the Emergency Regulations for Cerumen Management, in their current form, fail to recognize and respect this reality.   Unlike the regulations promulgated by other state boards of Audiology and Speech Language Pathology across these United States, the Virginia Emergency Regulations for Cerumen Management are unusually and unnecessarily restrictive.  Specifically:

• According to the Emergency Regulations specifically in 18VAC30-20-214.D An audiologist performing cerumen management shall;  1. obtain informed written consent of the patient or legally responsible adult and maintain documentation of such consent and the procedure performed in the patient record.  I request that the requirement of written informed consent be removed as a requirement for audiologists to perform cerumen management. 
  • While we are licensed to place ear tips and other accessories into the external auditory canal without written consent, the Emergency regulations require Virginia audiologists to obtain written consent prior to remove any ear wax FROM THE SAME ANATOMICAL REAL ESTATE of the patients we serve and treat.  This is unnecessarily and illogically restrictive.
  • Prior to seeing a patient, providers obtain consent for evaluation and treatment.  Does the Board propose that audiologists must obtain written consent for each portion of a patient interaction?  Prior to performing otoscopic examination?  Prior to conduction air and bone pure tone audiometry?  Prior to performing tympanometry and acoustic reflex testing?  Prior to performing optoacoustic emissions?  Prior to removing cerumen from hearing aid receivers or ear canals?  Prior to administering electrocochleography or auditory brainstem response?  Prior to performing any procedure, this audiologist informs the patient describes the procedure and obtains verbal consent.  To require written consent to perform cerumen management is illogical and unnecessary. Are physicians (or their assistants with far less expertise concerning cerumen management) required to obtain written consent before removing ear wax?  They are not. 
• Section C of 18VAC30-20-241, stipulates 11 contraindications to audiologist performance of cerumen management, requiring audiologists to refer any patients with a contraindication to a general practitioner or otolaryngologist for cerumen removal.  I suggest many of these conditions are cautions for and are not rigid contraindications for cerumen management.  Imposition of such restrictive contraindications imposes undue hardship (treatment delays, additional copayments and increased medical costs) to patients and their care givers, requiring that ongoing audiologic treatment (including hearing remediation) must wait until the contraindicated patient visits their general practitioner.   I view the following contraindications as unusually restrictive and request that they be removed as a contraindication:
  • Hearing in only one ear—I submit that audiologists are most sensitive to the implications of unilateral hearing loss and are well qualified to recognize when it is safe to remove wax from the ears of such patients. 
  • Current tympanostomy tubes—I submit that this audiologist is qualified to determine when said ear wax in the lateral portions of the ear canal can be removed without compromising tubes located in the tympanic membrane, deep in the external auditory canal.
  • Actual or suspect foreign body in the ear (I assume the regulations are referring to the external auditory canal): The current Virginia audiology scope of practice recognizes that audiologists are sufficiently trained to place EAR inserts, canal electrodes, Immittance and optoacoustic emissions ear tips as well as otoblocks or cotton blocks in patient external ear canals, as well as prior to making earmold impressions of the external ear canal and to remove said ear canal impression from the patient ear.  Audiologists regularly remove receiver domes from errant receiver in the canal hearing aids, portions of cotton swab heads that patients inadvertently leave in their ears, or other objects that may be visualized in the cartilaginous portion of the external auditory canal).
  • It is in the scope of practice to create and remove earmold impressions, but an audiologist cannot remove ear wax if a foreign body is present.  The foreign body can be removed, but the audiologist may not remove scant amounts of ear wax in the presence of a foreign body?  This is illogical and undesirable.    
  • Cerumen impaction that occludes the ear canal:   In the event of impaction that occludes the ear canal, audiologists have access to and use tympanometry to confirm intact eardrums prior to initiating treatment or prior to referring patients to an ENT specialist.  The Emergency Regulations now direct audiologists to send such patients to general practitioners and their assistants who do not have such technology available.
  • Traditionally, audiologists have been employed in hospital or otolaryngology practices where immediate referral to ENT services is available.  Across the Commonwealth, there are increasing numbers of independent audiology private practices where audiologists regularly provide safe, comprehensive audiological services. As one of these private practitioners, I regularly refer patients to an otolaryngologist when otoscopic inspection reveals pathology or conditions that contraindicate my safe removal of cerumen.  It is unethical for me NOT to make such referrals.  Yet, to compel me to stop treatment (that I am trained and experienced to provide) due to visibility of the tympanic membrane and/or external ear canal is also illogical and imposes undue hardship on the very patient that we seek to assist.
  • Diabetes mellitus, HIV Infection, bleeding disorder, or other medical contraindications: There are different levels of acuity in patients diagnosed with diabetes mellitus.  Patients with easily controlled diabetes present with better skin and canal health than do patients with fragile or poorly controlled diabetes.  The efficacy of contraindication of all diabetic patients by diagnosis rather than fragility or intensity of symptomology is questionable.  Refusing treatment to a patient with HIV infection is tantamount to discrimination.
• During the past fourteen years of private practice, more and more general practitioners physicians refer their patients to audiologists for safe cerumen management. As a sidebar, many patients regularly report that their experience of cerumen management by audiologists is much more comfortable and more efficient than management provided by their general practitioner—or support staff in that office.  General practitioners who do ‘provide’ such services typically defer cerumen management to their support staffwho typically have neither proper tools nor training to perform cerumen management.  They certainly do not conform to the training stipulated through the Emergency Regulations.  In its present form, the Emergency Regulations would send ‘contraindicated patients’ to health care providers who are less equipped to provide cerumen management than Audiologist licensees.  As noted previously, to mandate referral to other healthcare professional for simple and common conditions is in no way efficient patient care, nor in anyone's best interest.

Increasing numbers of citizens are home bound and cannot be easily transported to outpatient ENT practices because of their debilitated health and limited mobility.  The Emergency Regulations infer that audiologists who travel to such communities may no longer provide careful cerumen management in the safety of their home communities.  These patients will have to wait weeks for physician appointments and waste hours of time waiting their turn for treatment at the physician office—or will never receive treatment. 18VAC30-20-241.c

The American Academy of Audiology, the Academy of Doctors of Audiology, the American Speech Hearing Language Association and the Speech Hearing Association of Virginia all affirm cerumen management to be a part of the Audiologist Scope of Practice.  Access to the ear canal (and professional management of all aspects of complications that interfere with that) is the cornerstone of literally everything we do professionally. I urge the Board of Audiology and Speech Language Pathology to immediately revise the Emergency Regulations to be less restrictive to audiologists performing safe cerumen management

Dear Ms Knachel and Members of the Board of Audiology and Speech Language Pathology, 

As a nationally recognized authority in cerumen management training, it is with great interest and respect that I comment on the Virginia Title 18 Professional and Occupational Licensing Board Audiology Speech-Language Pathology Emergency Regulation performed by audiologists. Cerumen Management is considered part of the customary procedures of audiologists by national audiology professional organizations, as well as most of the state audiology license boards.

I, and others, have taught audiologists cerumen management workshops, distance learning courses for doctoral candidates, and classes for residential doctoral candidates since 1995.  The onsite classes are usually 6-10 hours depending on the needs of the institution.  Because audiologists are already trained in such areas as anatomy, physiology, and conditions of the ear and hearing, these areas are reviewed in the courses. The emphasis is on the methods of cerumen management including proper lighting and equipment.  The participants spend at least 2 hours practicing with actual instruments and equipment during the course. Depending on the setting, the participants will either have supervised practice among themselves, and/or actual volunteers are solicited from the community, who may have earwax.

It should be remembered that audiologists are already injecting and inserting foreign objects and materials (otoblocks, impression material, probe microphone tubes, transtympanic membrane electrodes, extended wear hearing aids, etc.) deep into the ear canal, oftentimes beyond the isthmus and second bend. Audiologists have had more than enough training by virtue of their university requirements and practical clinical experience to work in the outer ear, which, as you are aware, includes the ear canal up to and including the tympanic membrane.   Although it might be a hardship for a clinician in the rural areas of Virginia to obtain additional supervision in removal after such training, I am, in general, supportive of the training requirements specified in your guidelines.  Perhaps the requirement that demonstration after observation of each method could be required during a course.

Great emphasis, during these courses, is placed on contraindications for audiological management of cerumen.  A particular point is made that the clinician should only attempt to perform techniques within their comfort level. However, responding separately to each of the recommendations in section C of the emergency regulations let me note as follows:

C. An audiologist shall not perform cerumen management on a patient who is younger than 12 years of age or on a patient who has any of the following pre-existing contraindications:

1. Hearing in only one ear;

Understandably, an unqualified clinician might abuse the outer ear causing damage such that there is then a decrease of hearing binaurally. However, this would be the same concern for making an ear impression (such as for custom ear protection) which is not prohibited. At the very least, instrumentation should be permitted for a unilateral hearing loss.

2. A perforated tympanic membrane;

Only irrigation is contraindicated and, perhaps, aural suction. Once again, depending on the circumstance, at least instrumentation would be appropriate.

3. Inflammation, tenderness, or open wounds or traces of blood in the external ear canal;

I agree that these patients should be referred to a medical doctor.

4. Drainage from the external ear canal or middle ear;

I agree that these patients should be referred to medical doctor.

5. Current tympanostomy tubes;

Depending on the location of the cerumen, instrumentation is appropriate.

6. History of ear surgery, excluding past tympanostomy tubes or simple tympanoplasty;

Depending on the location of the cerumen, and the timing of the surgery, instrumentation is at least appropriate.

7. Diabetes mellitus, HIV infection or bleeding disorders;

There is no reason that these patients not be treated by an audiologist, provided use of universal infection control procedures and additional care to not be too aggressive in removing the cerumen.

8. Actual or suspected foreign body in the ear;

There is no reason that an audiologist, within their comfort level, be prohibited from removing hearing aid domes, wax guards, cotton blocks, bugs, dirt, etc. from the ear canal.  Once again, if placing and injecting foreign material (an otoblock, impression material) into the ear canal, at or beyond the second bend, and then removing it, is acceptable, then removing wax and foreign objects should also be included.

9. Stenosis or bony exostosis of the ear canal;

This, again, should be left to the comfort level of the audiologist, based on the degree of the impairment and the location of the ear wax.

10. Cerumen impaction that totally occludes the ear canal; or

Audiologists are taught how to soften the wax, treat it so that a tympanogram can be taken, and safely remove the wax. This should not be prohibited and proper training will teach the correct method(s) to use.

11. Inability to see at least 25% of the tympanic membrane.

Audiologists are taught how to soften the wax, treat it so that a tympanogram can be taken, and safely remove the wax. This should not be prohibited and proper training will teach the correct method(s) to use.
 

Another concern about restricting the scope of practice of audiologists removing cerumen is the time, stress, and cost imposed on a patient by having to see an additional health care provider.  Removal of cerumen may take as little at 5 minutes or, perhaps longer.  By requiring a patient to have this procedure performed by a different practitioner, this overbroad regulation would  unnecessarily increase the time the patient (and family member who transports the patient) must take off from work, create unwarranted stress from  needing to make yet another appointment, and incur  the burdensome cost of getting to the appointment and paying for it. All this is cast upon the patient when the treatment could have been done at the time the patient was with the audiologist, who is qualified, and in most other states permitted, to take care of the problem. 

Similarly, it could very well require a return to the audiologist for a hearing evaluation, hearing aid fitting, ear mold impression, etc. when it could all have been taken care of at the one visit to the audiologist. This type of duplication of services is a major contributor to the skyrocketing healthcare costs our nation has been crippled with over the last 10 years. Hopefully, the State of Virginia will take steps to help curb those unnecessary expenditures in at least this one area.

As a practicing audiologist for over 40 years, a clinical provider of cerumen removal for over 20 years, and a national instructor of audiologists in the procedures for safe cerumen management, I urge you to reconsider the restrictions you have placed on this essential audiology practice. Please don’t hesitate to contact me  if you have any questions or require additional information.

Respectfully,

Rita R. Chaiken, Au.D.

Doctor of Audiology

Dear Ms. Knachal and Virginia Board of Audiology and Speech Pathology Board Members,

We are writing, on behalf of the Academy of Doctors of Audiology (ADA), its Board and its membership, to comment on the Virginia Emergency Regulations as they pertain to Cerumen Management by audiologists.

While we commend you and your Board on the creation of much needed cerumen removal language, we believe that the proposed language is unnecessarily restrictive, poses a substantive barrier to care for Virginians and will result in other negative unintended consequences. 

ADA suggests broader language, similar to what is contained in its Scope of Practice statement (http://www.audiologist.org/scope-of-practice), which closely resembles the vast majority of licensure laws.  Since most state licensure laws contain language prohibiting licensees from performing any service or procedure for which they are not trained or competent and language prohibiting them from performing any action which could harm to patient, we feel that your current emergency language is overly restrictive and could cause more patient harm (reduced access, reduced affordability, injury by untrained personnel) with less benefit than more broadly written regulation. 

There are many such examples of more broadly written language available at http://www.asha.org/Advocacy/state/State-Cerumen-Management-Requirements/. We strongly encourage you to consider modifying your language to be more consistent with audiology’s current educational status and curriculum, the draft scope of practice language available from all of the national audiology associations, and the language that currently exists in the majority of the other states who address this in the United States.

Thank you for the opportunity to comment and for your consideration of our remarks.  Please feel free to contact our Executive Director, Stephanie Czuhajewski at sczuhajewski@audiologist.org with any additional questions or concerns.

Regards,

The Board and Staff of the Academy of Doctors of Audiology

Kim Cavitt, AuD, ADA President

Rita Chaiken, AuD, ADA President-Elect

Brian Urban, AuD, ADA Past-President

Angela Morris, AuD, Treasurer

Tom Goyne, AuD, Member at Large

Ram Nileshwar, AuD, Member at Large

Paula Schwartz, AuD, Member at Large

Alicia Spoor, AuD, Member at Large

Stephanie Czuhajewski, CAE, Executive Director

FEBRUARY 16,2015

DEAR MS. KNACHAL AND MEMBERS OF THE VIRGINIABOARD OF AUDIOLOGYT AND SPEECH PATHOLOGY:

MY NAME IS JEFFREY POWELL AND I AM THE FOUNDER AND SENIOR PARTNER OF EASTERN VA EAR,NOSE AND THROAT SPECIALISTS. I HAVE BEEN IN TIDEWATER,VA FOR 31 YRS. WE HAVE 8 PROVIDERS, 5 AUDIOLOGISTS AND A CLINICAL AND CLERICAL STAFF OF 80 IN 3  OFFICES IN THE TIDEWATER AREA OF SOUJTHEASTERN VA.  THE PURPOSE OF THIS LETTER IS MY DEEP CONCERN OVER  THE POTENTIAL CHANGE IN CM FOR AUDIOLOGISTS IN THE STATE OF VA. ALL OF OUR AUDIOLOGISTS ARE DOCTORAL LEVEL EXCEPT FOR OUR MOST RECENT HIRE. THEY ARE ALL HIGHLY COMPETENT IS ALL PHASES OF CLINICAL AUDIOLOGY, ESPECIALLY CM. I DO A LOT OF COMPLEX CHRONIC EAR SURGERY,AS DO MY PARTNERS AND WE RELY HEAVILY ON THE CLINICAL EXPERTISE OF OUR AUDIOLOGISTS. THEY ARE ALL HIGHLY SKILLED IN CM,FOREIGN BODY REMOVAL,EAC CLEANING ETC. THERE IS A VERY CLOSE 1:1 RELATIONSHIP BETWEEN THE MDS' AND THE AUDIOLOGISTS. 

AFTER REVIEWING THE DOCUMENTS FROM YOUR WEBSITE, I STRONGLY FEEL THAT ANY LEGAL LIMITATION PLACED ON AUDIOLOGISTS FOR CM WILL DO SIGNIFICANT HARM AND CONFUSION TO  ANY SMOOTH WORKING CLIN ICAL SETTING IN ANY OFFICE/CLINIC/HOSPITAL. THOSE OTOLARYNGOLOGISTS WHO EMPLOY THEIR OWN AUDIOLOGISTS HAVE, FOR  THE VAST MAJORITY OF PRACTIONERS, AN EXCELLENT EDUCATIONAL PROCESS AND  CLINICAL WORK SETTING THAT WILL INSURE PROPER AND APPROPRIATE CM.  I FEEL THAT THIS NEW LAW WILL SEVERELY COMPRIMISE AND CONFUSE AN ALREADY OUTSTANDING AND ESTABLISHED CLINICAL WORKING RELATIONSHIP. ONE MUST REALIZE THE THE MD WOULD DO NOTHING TO JEPORDIZE HIS/HER PATIENT AND HIS TRUSTED AUDIOLOGIST. IT IS A TEAM CONCEPT THAT HAS WORKED FOR DECADES AND IS "NOT" IN NEED OF ANY CHANGE. I COULD ALSO GET INTO THE MEDICAL-LEGAL ISSUES BUT SUFFICE IT TO SAY FROM ONE WHO DOES A LOT OF INSURANCE CLAIM REVIEWS AND LEGAL CASE  ANALYSES, I CAN SAY WITH A REASONABLE DEGREE OF MEDICAL CERTAINTY THAT THE CURRENT STATUS OF CM WITH AUDIOLOGISTS SEEMS QUITE REASONABLE AND SENSIBLE.  I REALIZE I CAN ONLY SPEAK FOR MY STATE OF VA. (PAST PRESIDENT OF THE VA SOC OF OTO/H&N SURGERY AND OF THE TIDEWATER OTOLARYNGOLOGY& OPTHALMOLOGY SOC.). 

I SINCERELY HOPE THAT YOU AND THE BOARD MEMBERS FIND MY COMMENTS USEFUL AND HELPFUL. WE ARE VERY COMMITTED AND DEVOTED TO OUR AUDIOLOGISTS AND THE MANY FACETS OF OUR CLINICAL PRACTICE THAT THEY ARE SO VITAL FOR (ADVANCED CHRONIC EAR SURGERY, STAPEDECTOMY, HEARING AID ANALYSIS AND FITTING, AUDITORY INTEGRATION DISORDERS, NEWBORN ABR SCREENINGS, PUBLIC SERVICE LECTURES FOR YOUNG AND OLD ALIKE, COMPLEX MEDICAL-LEGAL CASES, NOISE-INDUCED HEARING LOSS AND TINNITUS...ANALYSIS AND IF NEEDED PARTICIPATION IN THE LEGAL ARENA WITH THE OTOLARYNGOLOGIST.

LASTLY, IF YOU LOOK AT ALL THE CLINICAL PEOPLE WHO ARE INVOLVED IN CM, (ESPECIALLY NON-ENT PERSONEL), AUDIOLOGISTS FAR AND AWAY ARE NEAR THE TOP OF COMPETENT AND COMPASSIONATE PROVIDERS. I STRONGLY SUPPORT ALL AUDIOLOGISTS NATIONWIDE AND IF I CAN BE OF ANY ASSISTANCE IN THIS MATTER I WOULD MORE THAT HAPPY TO HELP OUT.

RESPECTFULLY SUBMITTED:

JEFFRFEY P. POWELL,MD,DDS,FACS.

CLINICAL ASSOCIATE PROFESSOR DEPT OF OTOLARYNGOLOGY/HEAD & NECK SURGERY and  FAMILY MEDICINE

EASTERN VIRGINIA MEDICAL SCHOOL, NORFOLK,VA.  (757) 547-9714

Dear Ms. Knachel and Members of the Virginia Board of Audiology and Speech Language Pathology,

As a practicing audiologist since 1976, the last twenty in private practice, I read the proposed "limited cerumen management" regulations with concern.  Having served two terms on the Board (five as Chair), I applaud the Board's willingness to address the cerumen management issue and the audiologist's role.

The regulations, as proposed, would have a very restrictive effect on the actual practice of audiology and the care of our patients.  As you know, both AAA and ASHA include cerumen management within the scope of practice of audiology and do not define limitations. After reviewing neighboring states' regulations, including West Virginia, Maryland and North Carolina, all of whom include cerumen management within the scope of practice, none are as restrictive as the currently proposed regulations. Most of the contraindications listed in Section C of 18VAC30-20-241 are addressed  in the Maryland regulation (Chapter 07, 04 Training, Knowledge, and Skills) with one critical difference. Maryland stipulates that the pre-existing conditions be addressed through training and does not bar the audiologist from performing cerumen management as does the Virginia proposal.

Audiologists are categorically one of the best trained disciplines to perform cerumen management. Through my practice, I have encountered many patients who have just seen their primary care physician who has referred them on for audiological assessment. Most of the time, some amount of cerumen is present which was not removed by the physician prior to the appointment.  As you are aware, patients who wear hearing aids are at risk for developing blocked canals due to the daily insertion of a device. By restricting the audiologist's role, these patients will not be able to receive this essential service to obtain accurate test results or maintain comfortable use of their aids. Patients will have to wait weeks, and in some cases months, to be seen by an otolaryngologist for ear cleansing, which will also add extra costs to their care. For example, Section C, item 8 bars an audiologist from removing an "actual or suspected foreign body in the ear." As read, this would prevent me from removing a hearing aid eartip which has dislodged in the canal. Most tips are very easy to remove. Rather than quickly taking care of the problem in my office, I would have to refer out and the patient would incur an unnecessary medical charge.

Currently, in my locale, there are providers of cerumen removal who do not require any guidelines. One of these treatments is known as candling, which involves placing the smaller end of a tapered cone near the opening of the ear canal. The cone is made of cloth soaked in beeswax or paraffin. The larger end is lit and the heat is said to create suctioning which "draws" the cerumen from the canal. To date, I have not encountered anyone burned or injured by the procedure but do not advocate its use. The point of this example is to further stress the need for our profession to be able to provide cerumen management without the proposed restrictions so that our patients have reasonable accessibility and choice as to where to obtain service.

As I have watched our profession evolve through the years, developing greater  autonomy by becoming a doctoral level profession, I would think that we would trust the judgment of the professionals trained through our universities.  Currently, those of us dispensing hearing aids are taking ear impressions that extend deep into the ear canal. Practitioners who assess the vestibular system are introducing either water or air when irrigating the canal for calorics. All of these skills involve risks which our training has addressed.

Instead of developing a restrictive approach to cerumen management, which will have unintended consequences for the patient, the practitioner and the profession, I recommend that training be stressed as the defining point for performing cerumen management and let the audiologist use his or her professional expertise and judgment to determine where the service should be done. I am asking the Board to take into consideration the burden these regulations will place on the patient and the practitioner. Rather than moving forward with the current draft, I suggest that further study be undertaken to ensure that the regulatory change is appropriate and does not damage our patient's access to service. 

If we are now a doctoral level profession, shouldn't we act as such?

Respectfully,

Julie Farrar-Hersch, Ph.D.

Augusta Audiology Associates, P.C.

With regard to the proposed emergency regulations to the Audiology License in the Commonwealth of Virginia:

I have been a licensed audiologist in California, Louisiana, and for the majority of my career, in Virginia.  I have been trained to remove cerumen decades ago by an otolaryngologist, and have refined my skills during the years working with other otolaryngologists and audiologists.   I can remove cerumen using suction, irrigation, and instrumentation (loops, forceps, etc.).   In addition, I have removed cerumen in newborns while performing newborn hearing screenings and have taught nurses and pediatricians how to remove cerumen in infants.  I have removed cerumen and foreign bodies from all ages and sizes of ear canals.  I have removed cerumen that was totally occluding a canal, patients with diabetes, previous ear surgery, and those on anticoagulants.

In 2006, while taking an Au.D. Course specifically on cerumen removal, one of my tasks was to survey the Board to find out if there were regulations.  I was verbally told, and emailed (not available now) that there were no regulations, BUT if an audiologist was trained to remove cerumen, it was allowable.  The Board trusted than an untrained audiologist would not attempt to remove cerumen and would refer appropriately.

In good faith, I have been providing this service for years.  I appreciate the Board’s desire to have a formal regulation in place within our licensure law.  However, what is proposed is rather limiting to those audiologists who do have training and experience.

For example, several physicians refer patients to me for cerumen removal, because they do not have the necessary equipment or time.   My community does not have a local ENT.  If every trained audiologist were to stop removing cerumen, this would be an inconvenience to many patients and even their physicians.  I wonder if any nurse, nursing assistant, medical assistant, and even primary care physician has the in depth training, experience and equipment that I do as an audiologist to remove cerumen.  Recently, a patient decided to have cerumen removed in their physician’s office.  The patient returned to me with pools of dried blood in each canal, reporting how painful it was.

I respectfully suggest that the severe limitations be removed from the proposed language.  Our board needs to trust that the licensed audiologists in the Commonwealth will ‘do no harm’ – respect our limitations and if we are not comfortable performing a procedure, refer out.

I personally do not have a problem requiring a consent form prior to the cerumen removal procedure, as this is standard practice in most medical/ para medical offices when any procedure is done.

Thank you for the opportunity to contribute to this proposal.

With regards,

Donna M. Mallory, Au.D., CCC-A

As an out of state audiologist, I would like to humbly provide my comments for review.  I believe that the language currently proposed is too restrictive.  Audiologist are trained, and have the skills and clinical knowledge to assess the ear canal.  Cerumen management is less invasive in many cases than the insertion of a Lyric hearing aid or taking of an earmold impression.  I believe that patients safety is the most important issue, but in my area many primary care physicians have nurses or nursing assistants perform cerumen management under the doctor’s supervision.  Because many of the nurses are not properly trained for cerumen removal the practices as a result do not provide this service.  It then requires patient's to pay a specialist co-pay to see an ENT and often incur additional charges for flexible endoscopy as the ENT is now needing to provide a full exam for due diligence.  Audiologist are the most cost effective and properly trained professionals to be removing cerumen.  Please consider using broader language in defining the scope of practice, to allow audiologist to continue providing this much needed service. 

RE:  COMMENT ON EMERGENCY REGULATION ON CERUMEN MANAGEMENT

Introduction

My name is Leah Ball and I am a founding member of Richmond Hearing Doctors, PLLC.  I have been practicing audiology for more than 20 years, during which time I have practiced at two large academic medical centers, including Tripler Army Medical Center in Honolulu, Hawaii and, more recently, the University of Virginia Medical Center.  I have also practiced in a large, private otolaryngology practice in Richmond, and at three different private audiology practices, including my current practice at Richmond Hearing Doctors.   Throughout my career, I have seen audiologists throughout the country, including here in Virginia, provide cerumen management services to patients in need. 

I write to address the emergency regulations promulgated by the Board of Audiology and Speech-Language Pathology (“the Board”) governing the performance of cerumen management, and also the Board’s intent to promulgate permanent regulations.  The Academy of Doctors of Audiology, the American Academy of Audiology, and the American Speech-Language Hearing Association have unanimously defined the audiology scope of practice to include cerumen management.  To the extent the Commonwealth of Virginia and the Board have chosen to overtly recognize cerumen management as falling within the scope of practice for audiology, I applaud their actions.  Cerumen management is an essential skill in the practice of audiology.

Comments on Emergency Regulations

Unfortunately, two aspects of the emergency regulations are cause for concern.  The first is the definition of “limited cerumen management,” which limits audiologists to the removal of cerumen from the outer one-third of the external auditory canal.  This definition is unnecessarily restrictive.  When cerumen removal is necessary to diagnose, assess, or treat a hearing disorder, it is common for cerumen to exist throughout the full depth of the ear canal.  Provided the audiologist has the necessary training and experience – criteria that are validly defined by the Board – the audiologist should be given the professional discretion to perform the necessary cerumen removal.  There is no apparent clinical basis for limiting such removal to the outer one-third of the auditory canal, and doing so significantly increases the number of patients who must be referred to a physician for a service that falls well within the training and experience of many audiologists.  

The second and more troubling aspect of the emergency regulations is the expansive list of preexisting contraindications.  The list of contraindications includes categories of patients who frequently have the greatest need for cerumen management services, and will therefore suffer the greatest limitation in their access to care.  This includes diabetics, for whom hearing impairment is twice as common then in patients without diabetes.  It is not uncommon for an audiologist in private practice to see at least one patient a day who has diabetes, and yet the emergency regulations prohibit that audiologist from using even a small cerumen loop to remove wax during the patient’s quarterly hearing aid check-up. 

Admittedly, there are valid contraindications for cerumen removal, but trained audiologists recognize these conditions when they present themselves clinically.  For example, audiologists are well trained and understand that perforation of the tympanic membrane, or the presence of a myringotomy (PE) tubes, are universal contraindications for cerumen management by ear canal irrigation. When appropriate procedures are followed, including the referral of patients with very special needs, risks associated with cerumen management are negligible.   

The obligation to identify clinical indications, or contraindications, for a medical procedure is best left with the individual practitioner, rather than being defined by regulation.  Imagine for a moment that the practice of medicine were defined as including surgery, but only when the surgery is not contraindicated by a specific list of medical conditions.  Such an effort to define the scope of medical practice by reference to a defined list of contraindications would, in additional to being unworkable, would invariably deprive the physician of the professional discretion that is inherent in his or license to practice medicine, and consequently deprive the patient of the physician’s professional judgment.  The same is true for audiologists.  Audiologists who possess the education, training, and experience to engage in the practice audiology (and who are bound by a professional code of ethics and community standards of care) can best serve their patients when they are given the professional discretion to determine when a particular treatment or service is clinically indicated, including cerumen management.  

In short, the statutory directive that the Board “promulgate regulations governing cerumen management by audiologists, which shall include requirements related to training and qualifications of audiologists who perform cerumen management,” may be complied with fully by prescribing training and qualifications for audiologists who remove cerumen.  There is no statutory requirement for the Board to establish a narrow definition for “limited cerumen management” or to delineate specific contraindications for cerumen management, and I would urge the Board not to do so.  

Adverse Impact of Overly Restrictive Limitations

Implementation of the emergency regulations is already having, and will continue to have, an adverse impact on a large patient population.  The emergency regulations require all audiologists, even those with appropriate training and experience in cerumen removal, to refer large categories of patients (including, for example, patients whose tympanic membrane is not at least 25% visible, or who have hearing in only one hear, or who have diabetes) back to their primary care physician.  It is commonly known that physicians rarely remove cerumen themselves, but instead delegate the procedure to nurses who frequently have minimal training and experience, if any, in cerumen management.  In addition, it is uncommon for primary care physician practices to have the equipment necessary to provide cerumen management with gentle irrigation or gentle suction.  As a result, attempts to remove cerumen in primary care practices are often unsuccessful.  These physicians, many of whom have historically developed relationships with private audiology practices where the reputation for excellent care has been proven, are now forced to send a significant number of patients to an ear, nose, and throat (“ENT”) physician. 

In short, the emergency regulations have resulted in many patients being referred to primary care physicians who either cannot, or do not want to, provide cerumen management, and who must in turn refer those same patients to ENT physicians who are wondering why they must personally provide a service that was previously delegated to employed audiologists. 

Residents of nursing facilities and residential retirement communities find it even more difficult to receive treatment of cerumen impaction than the typical patients described above, and many; in fact, remain impacted even after a nurse attempts to remove the cerumen.  While primary care physicians routinely visit residents in nursing facilities, they rarely (if ever) provide cerumen management.    Historically, audiologists who hold clinic in nursing facilities and residential retirement communities have been available to provide cerumen management services to patients without the need for transportation out of the facility and at a fraction of the cost of a physician visit.  Pursuant to the emergency regulations, many of these patients (including those who suffer from diabetes, have hearing loss in one ear, or who have a total or near total impaction) will now have to be transported to a local ENT office.  When the time required for transportation, which must often be accomplished by van or bus, is combined with the typical wait at a busy ENT practice, many patients will now spend hours away from a medical care facility just to have ear wax removed, when previously they could have gotten the same service in a matter of minutes without leaving the facility. 

As the circumstances above illustrate, the emergency regulations have dramatically impacted the way in which patients receive cerumen management services in Virginia, without any clear benefit in quality of care or patient safety. 

Requested Action

For the reasons expressed, I request that the Board consider the following actions:

1.  Amend or revise the emergency regulations as soon as possible.  The legal authority to do so is contained in Virginia Code Section 2.2-4011.C., which states the following: “C. All emergency regulations shall be limited to no more than 18 months in duration. During the 18-month period, an agency may issue additional emergency regulations as needed addressing the subject matter of the initial emergency regulation, but any such additional emergency regulations shall not be effective beyond the 18-month period from the effective date of the initial emergency regulation.
2. Amend the definition of “limited cerumen management” in 18VAC30-20-10, as shown below. "Limited cerumen management" means the identification and removal of cerumen from the cartilaginous outer one-third portion of the external auditory canal in accordance with minimum standards and procedures set forth in this chapter.
3. Delete the list of preexisting contraindications listed in 18VAC30-20-241.C.  Audiologists would still be required to recognize the existence of contraindications that require referral to a physician, as stated in 18VAC30-20-241.B.1., but the deletion of subsection C would restore audiologists’ professional discretion to determine when a contraindication exists.

Thank you for your consideration of these comments.

Sincerely,

Leah D. Ball, Au.D. 

Richmond Hearing Doctors, PLLC

As a future audiologist in this promising career, I strongly advocate for the revision of the existing emergency regulation on "limited cerumen management" to include what audiologists are meant to do, should be able to do, and have been successfully doing!

Simply put, cerumen removal has always been in the scope of practice for the field of Audiology. Audiologists provide service and care for every component of the ear and auditory system, why should it stop with ear wax? As a future clinician, the last thing I want to tell my patient is "you have too much wax for me to conduct any tests, you need to see a doctor first, then come back to me." Their response would make perfect sense: "you can look in my ears, stick probes in my ears, test my ears, put impression material in my ears, put hearing aids in my ears... shouldn't you be able to take something out of my ear?" The answer should be yes.

This issue takes an undermining turn when these patients are sent away to the doctor’s office, only to have a nurse (who did not study and train for 2-4 years in the field of ears, hearing, and audiology as an audiologist did) take the wax out themselves. Audiologists are already trained to be gentle, careful, and precise when working in and around the ear/canal. They already do more invasive services for patients, such as make ear-mold impressions, conduct Real Ear hearing aid measurements, and insert Lyric hearing aids, just to name a few. An audiologist should be allowed to (re)move wax/objects from the ear canal in order to achieve proper service for their patients. Also they should not be so strictly regulated as to when it is appropriate to do so. The extensive education that is required by the audiologist's degree should suffice as qualification that the audiologist can judge a situation to make the best and safest possible decision as to how to manage a patient's wax/foreign object.

The regulation restricts audiologists from conducting cerumen management for several conditions, all of which are either too conservative or are obvious enough to trust an audiologist's discretion to make the call against it. For example, if a patient can only hear out of one ear, that should NOT prevent cerumen removal, it should encourage it. I myself have a dead ear and a hearing ear, and I am VERY protective and nervous about anything happening to my one functioning ear. If I were to have total wax occlusion in my good ear canal, then imagine how much more trouble I would have hearing out of the only ear I rely on? If I had a foreign object in my good ear canal, then imagine how nervous I would be that it could cause damage to my tympanic membrane or something worse? As a person with single-sided deafness, I would WANT an audiologist to remove wax/foreign bodies EVEN MORE eagerly than if I had two working ears. As another example, if a patient has a foreign body in the ear, that should NOT prevent an audiologist from removing it. The object could cause harm to the patient if not removed, and who better to remove it than an audiologist or an ENT (hopefully not a nurse!). What if the object was something from the audiologist's clinic itself? Such as an earphone insert, ear mold impression material, or a hearing aid dome... it should be understood that an audiologist knows these items the best and is qualified to remove these items for the benefit and safety of the patient... it should also be understood that audiologists are smart enough to make the right decision as to when it is appropriate to do so.

The list of reasons goes on and on. As a future audiologist, my goal is to use my education and degree to service all my patients in the FULL scope of practice that an audiologist is responsible to uphold. That of course is including managing and removing wax/foreign objects for the benefit of my patients. I would be highly disappointed and discouraged (for myself and for my patients) to find out that the state of Virginia restricts me in this career goal.

Thank you for taking the time to consider my thoughts and opinions, especially as a student of the field.

Sincerely,

Sofia Ganev

The proposed cerumen management regulations are too restrictive. It has not been made clear to us why there is a sudden need for emergency regulation. I would suggest that this could be discussed at the SHAV meeting in Richmond March 25-28.

February 23, 2015

Dear Ms. Knachel:

The American Speech-Language-Hearing Association (ASHA) is the national professional, scientific, and credentialing association for more than 173,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students. Over 3,880 members reside in Virginia.

On behalf of ASHA’s members, I am writing to provide comment on the proposed audiology rules and regulations governing cerumen management. As the leading national organization for the certification and advancement of audiologists and speech-language pathologists (SLPs), we have significant concerns regarding the limitation of audiologists to complete cerumen management.

Cerumen management results in the removal of debris from the external auditory canal to facilitate the performance of other audiologic procedures and/or to improve hearing sensitivity. Audiologists are the leading providers of hearing management and are working within their scope of practice to perform cerumen management without limitations.

ASHA has policy documents and related references in regard to external auditory canal examination and cerumen management. These references include a document describing ASHA’s Scope of Practice Clinical Practice Algorithms and Statements. These service delivery guidelines can be accessed on ASHA’s website at www.asha.org/policy/g11999-00013.htm, www.asha.org/policy, and www.asha.org/policy/sp2004-00192.htm.

ASHA’s preferred practice patterns include external auditory canal examination and cerumen management. An external auditory canal examination should be performed on all patients in preparation for other audiologic procedures with cerumen removal to be performed by mechanical removal, irrigation or suction, and appropriate referrals made for further management as required.

ASHA has been receiving comments and concerns from its members in the Commonwealth of Virginia regarding the proposed rules and regulations limiting the practice of cerumen management for audiologists who are already highly qualified to provide cerumen management services in Virginia.

We sincerely appreciate the Board’s efforts to make cerumen management services safe for the consumer. However, decreasing the scope of practice for audiologists eliminates key skills that are the cornerstone of the profession and puts patients at risk for receiving services from less qualified providers. Audiologists, acting within their scope of practice, should be able to use their professional judgment to determine when an additional referral is appropriate and when procedures should or should not be performed.

We ask that you eliminate limitations and allow licensed audiologist to treat and make referrals for cerumen management, when appropriate.

Thank you for the opportunity to provide comments. Should you have any questions, please contact Cheris Frailey, ASHA’s director of state education and legislative advocacy, at cfrailey@asha.org, or Janet Deppe, ASHA’s director of state advocacy, at jdeppe@asha.org.

Sincerely,

Judith L. Page, PhD, CCC-SLP

2015 ASHA President

Dear Ms. Knachel and Members of the Virginia Board of Audiology and Speech Language Pathology,

As a licensed and certified audiologist in the state of Virginia, I find the emergency regulations for cerumen management too limiting and restrictive.  I am currently employed at Western State Hospital, a Virginia state hospital for consumers with mental illness.  The majority of the individuals that I test at this facility are indigent.  The proposed limitations/contraindications would prohibit me from working with the majority of individuals within this hospital.  It would also place an undue burden on these consumers to try to obtain safe and qualified hearing care services, especially cerumen management, in a timely manner, if at all.  For the sake of the consumers across Virginia, please reconsider the limitations and restrictive language in this emergency regulation on cerumen management by audiologists.

Sincerely,

Daina A. Sisk, M.Ed. CCC-A

My name is Paul D. Kuster, Au.D. I have been a practicing audiologist since 1996 and have been a Doctoral level audiologist since 2004. I have been a member of ASHA and AAA and continually licensed first in West Virginia and now in the Commonwealth of Virginia for all of that time. For my entire career, cerumen management has been a daily reality and stated privilege under the Scope of Practice of both of my credentialing organizations. My specialty and the focus of my career and business is the dispensing of hearing aids. I cannot conceive any way that I could practice without the ability to freely access the ear canal, and using my nearly two decades of experience and clinical, professional judgment, manage my patient’s cerumen - in my own office, at the moment they are there with me, to the limits of my ability to do so, and, if in my professional judgment, refer to medical specialist’s conditions that require medical intervention. To have mandated referral to other healthcare professionals for simple and common conditions is in no way efficient patient care, nor in anyone's best interest. I have to date written many missives and have had lengthy conversations with regional and nationally recognized leaders in the field of Audiology regarding the proposed regulations, and every one of them has found the language to be unnecessarily restrictive. I have been unable to find any evidence that audiologists are harming patients through negligent practice. My professional liability insurance is cheaper than the professional dues required to keep my affiliations, a sure sign that we as a profession are being careful to do no harm. The comment board is replete with the information needed for the Board to make its decision. I have been working closely with Dr. Leah Ball, a longtime acquaintance and similarly situated colleague and so will not go on and list all of my issues. I will simply state that I am in complete agreement with Dr. Ball’s recommendations, to wit: Amend or revise the emergency regulations as soon as possible, amend the definition of “limited cerumen management”, and delete the list of preexisting contraindications. I am comfortable that I can manage cerumen in a safe and professional manner and am certain that I can recognize both my limitations and any pathology that would endanger my patients’ health. I appreciate the respect and diligence of the Board members in addressing my concerns.

Paul D. Kuster, Au.D.

Doctor of Audiology

CCC-A, F-AAA

There are a lot of good comments on this board, so I do not need to repeat what has been said. I would like, however, to provide my personal experience with cerumen management.

I have been a licensed audiologist in Virginia since 1997. I initially practiced in an ENT setting, and was trained in cerumen mangement by a Ph.D. audiologist as well as the physicians. The physicians were more than happy to have me take care of the less complicated cases. I performed cerumen management initially via curettage through an articulating otoscope, and over time developed skills with aspiration and lavage. As part of my Au.D. curriculum, I took a course in cerumen management. 

Currently, my cerumen management skills (and equipment) exceed those of any nurse or physician I know of in the area (excluding otolaryngologists). Many of my patients report that if cerumen management was necessary at their PCP's office, they were handed off to a nurse (LPN, RN) for a lavage. It infuriates me that someone with less than 2 years of medical training, and no formal training in cerumen management can perform these services in a physician's office, but a doctor of audiology in her own practice cannot. 

I perform cerumen management skillfully, quickly, and painlessly on my patients. I am comfortable with my skills, and also know my limitations. I refer to ENT as necessary. It would a disservice to my patients to refer them out based on the restrictions the board has presented. Many of my patients will be greatly dissatisfied if I have to refuse them my cerumen management services.  Many of them remark that I am very good at it, and would not like to be forced to have someone with less experience and training perform these services. I do not charge them for it, it is included as part of their hearing evaluation. With the new restrictions, I will need to refer many of my patients out, forcing them to pay co-pays to their physician, take off more time from work, get another ride, etc. 

An anecdote about foreign body removal restriction: a patient of mind had a rubber dome from a hearing aid stuck in his canal. It was over the weekend, so he went to urgent care. Nurse #1 said there was nothing in his ear (although it was completely occluding his canal) . Nurse #2 identified it and attempted to remove it. It resulted in extreme pain, and still not removed. He decided to leave and just wait until Monday to see me. On Monday I strapped on my headlamp and popped out the dome with forceps almost immediately. I gave him my cellphone number and told him to call me next time if it happens over the weekend. 

These are MY patients, some of them I have been treating for close to 18 years. Many of my patients fall into the new restrictive categories, and I would be forced to turn them away from a service I can skillfully provide. 

Ms. Knachel and Members of the Virginia Board of Audiology and Speech Language Pathology,

My name is Debra Flechner Ogilvie and I have been a licensed Audiologist in the Commonwealth of Virginia for 20 years.  I have worked mostly in private practices, most recently as a joint Owner in Richmond Hearing Doctors, PLLC.  I am commenting on the Emergency Regulation regarding performance of cerumen management by audiologists [18 VAC 30 - 20].

As many have already stated on this forum, I also believe this regulation is too restrictive and limiting for professional, licensed Audiologists – many of which have already have a Doctoral degree.  The national organizations that regulate the field of Audiology already have cerumen management listed within the scope of practice for Audiologists (http://www.asha.org/policy/sp2004-00192.htm, http://www.audiology.org/publications-resources/document-library/scope-practice, and http://www.audiologist.org/scope-of-practice) and these new regulations limit our practice rather than expand it, it was hoped to do.  “Limited” cerumen management is unnecessary since Audiologists are trained and knowledgeable about the entire outer ear canal where cerumen can develop and needs to be managed.  We are all in agreement that cerumen management is an advanced procedure and this needs to be fully within the scope of practice of an Audiologist – especially a Doctor of Audiology – without limitation on a portion of the ear canal that has no clinical basis.

This list of contraindications listed in Proposed Section 241 Subsection C is the most limiting aspect of the Regulations.  As a well-trained Audiologist (and anyone else going through the continued training as outlined in subsection B), I would know who and when to refer to an Otolaryngologist. Our Audiology License and Codes of Ethics already prevent us from performing procedures from which we are competent, appropriately trained, and/or comfortable performing on a patient and/or which could cause harm to the patient. In the past, physicians have already been referring to Audiologists because they know and trust us as competent professionals to remove cerumen, and refer appropriately. Patients have frequently commented that they prefer coming to Audiologists for the comfort and

Subsection D: Audiologists are doing many other procedures that do not require written consent so why would this? If there is going to a signed consent, it should also include an informed consent waiver for any of the contraindications that may unfortunately stay within the regulation.

While I have many reservations about this Emergency Regulation, I appreciate the work the Board has done on behalf of Audiologists and the citizens of Virginia.

Dear Ms. Knachel:

The American Academy of Audiology (the “Academy”) appreciates the opportunity to offer comments in response to the emergency regulation issued by the Virginia Board of Audiology and Speech-Language Pathology regarding the performance of cerumen management by audiologists. The Academy is the world's largest professional organization of, by, and for audiologists, representing over 12,000 members. The Academy promotes quality hearing and balance care by advancing the profession of audiology through leadership, advocacy, education, public awareness, and support of research.

The Academy appreciates the Board of Audiology and Speech-Language Pathology’s commitment to ensuring that patients in the commonwealth of Virginia receive high quality hearing health-care. The Academy recognizes the importance of the Board’s decision to further define cerumen management as part of an audiologist’s scope of practice in Virginia, a positive step for audiologists and patients alike. It is also the Academy’s position that any regulations issued to define the performance of cerumen management by audiologists should accurately reflect the education, training, and scope of practice of an audiologist, and should be written in a way that accounts for emerging technologies, best practice guidelines, and educational standards.  The Academy has reviewed the emergency regulation and respectfully submits the following points for your consideration.

Cerumen Management and Audiology Scope of Practice

The Academy is concerned that as written, the emergency regulation for cerumen management, will restrict the ability of the audiologist to provide services within their scope of practice.  Audiologists are highly educated, trained, and qualified to perform cerumen management. Cerumen management is and has been a part of the curriculum for the Doctor of Audiology degree (AuD) for more than twenty years, as described in the Knowledge and Competency Standards for the AuD outlined at http://www.audiology.org/publications-resources/document-library/proposed-academic-performance-standards-aud-degree . This specialized level of education and training means that audiologists are among the most qualified providers to perform cerumen management.  In many instances, it is common practice for physicians to refer their patients to an audiologist for safe and effective cerumen management. If an audiologist determines that there is medical condition that will prevent the safe practice of cerumen management, the audiologist will refer that patient to a physician. Additionally, the Academy’s Code of Ethics clearly states that audiologists shall only provide those professional services for which they are qualified by education and experience, and shall refer to other specialties when necessary. The Academy’s Code of Ethics can be accessed at http://www.audiology.org/publications-resources/document-library/code-ethics . Audiologists are ethically, and most often legally, bound to adhere to these important principles of professional conduct and to act in the best interest of the patient.

Limiting the ability of an audiologist to perform cerumen management could adversely affect patients. Safe cerumen management is a key factor in the fitting of hearing aids, and restricting the audiologist from performing this service could affect the audiologist’s ability to properly fit a patient’s hearing aid, or even to perform an accurate audiologic assessment. This creates barriers to care including multiple, unnecessary office visits, thus resulting in a negative experience for the patient by delaying the proper and comfortable fitting of hearing aids.  

To account for the important role of the audiologist in performing cerumen management, and ensure that state regulations reflect this practice, the Academy supports the adoption of broader language that more closely resembles the language found in its Scope of Practice document, available at http://www.audiology.org/publications-resources/document-library/scope-practice.   This less restrictive approach is on par with the regulations, laws, or policies enacted in the majority of other states that include cerumen management in an audiologist’s scope of practice, including the states that neighbor Virginia: North Carolina, West Virginia, and Maryland.

Proposed Modifications to Section: 18VAC30-20-241. Limited cerumen management.

The Academy would also like to draw your attention to section 18VAC30-20-241, which states the following: “A. In order for an audiologist to perform limited cerumen management, he shall: 1. Be a graduate of a doctoral program in audiology which is accredited by the Council on Academic Accreditation of the American Speech-Language-Hearing Association and which included didactic education and supervised clinical experience in cerumen management as specified in subsection B of this section; or…”

The Academy strongly encourages the Board of Audiology and Speech-Language Pathology to consider alternative language that represents the current landscape in audiology education accreditation. The Accreditation Commission for Audiology Education (ACAE), not referenced in the current language, is an active accrediting body for audiology education and received recognition and approval from the Council of Higher Education Accreditation (CHEA) in 2012. The Academy urges the Board of Audiology and Speech-Language Pathology to recognize the ACAE in section 18VAC30-20-241, or to adopt language that is more neutral and inclusive.  

The Academy would like to thank the Virginia Board of Audiology and Speech-Language Pathology for the opportunity share our position regarding cerumen management by audiologists as outlined in the emergency regulation. We hope that the Board will consider adopting language that is less prescriptive for qualified audiologists providing safe cerumen management, and modify the emergency regulation to include other accrediting organizations. Please contact Kate Thomas, director of payment policy and legislative affairs at 703-226-1029 or kthomas@audiology.org  if you should need additional information or clarification regarding the Academy’s comments.

Sincerely,

Erin L. Miller, AuD

President

American Academy of Audiology

I wanted to take a moment to express my deep concern over the emergency limits regarding Cerumen Management by Audiologists and any proposed future limits for Cerumen Management (CM). As an audiologist I received more than sufficient training to perform cerumen management and to recognize when specialized attention from an Ear Nose and Throat Physician was indicated. I agree with the statements of my colleagues who have already pointed out that unlike many nurses, nurse practitioners and physician's assistants, our training specifically includes cerumen management. It is absurd to think that an audiologist could take a deep ear canal impression, place a electrode on the ear drum, or place a Lyric hearing aid and not be able to remove those things. Cerumen Management by the audiologist is also an effective way to help reduce unnecessary medical expenses.  It has been my personal experience that my ability to perform CM has been appreciated in both the hospital and ENT Physician's Office settings. Licenses and ethical obligations prevent audiologists from performing cerumen management without proper training, skill and comfort with the procedure. Rather than trying to restrict the scope of practice of the Audiologist, we should be celebrating their contribution to the medical care of Virginians.

Dear Ms. Knachel and Members of the Virginia Board of Audiology and Speech-Language Pathology,

I am an audiologist with over thirty years of experience in various settings, the last twelve in a private practice setting.  I am concerned about several items on the Emergency Regulations for Cerumen Management.

The first is Section C, Item 2, which states a "perforated tympanic membrane" as a contraindication to audiologists performing cerumen management.  Impedance testing, whcih is readily availably in audiologists' offices but often not readily available in physicians' offices, can easily be used to help determine the presence of a perforated tympanic membrane.  Therefore, it is my opinion that Section C, Item 2, a "perforated tympanic membrane" be removed as a contraindication to any cerumen management for audiologists.

Section C, Item 7 lists diabetes mellitus, HIV infection, or bleeding disorder as contraindications to audiologists performing cerumen management.  It would seem that well-controlled diabetes would not be a contraindication to cerumen management for the audiologist since the canal membranes would be strong and intact and not especially vulnerable.  So, I would ask that diabetes mellitus be removed from the list of contraindications to audiologists performing cerumen management. 

Section C, Items 10 and 11 state that cerumen impaction that totally occludes the ear canal, or the inability to see at least 25% of the tympanic membrane is a contraindication to audioologists performing cerumen management.  In order to do our primary job, which is evaluating hearing, we must have a clear route for the test tones to travel.  To interrupt the hearing appointment for the patient, who often has difficulty travelling, to go to a physician's office for cerumen management is cumbersome at best and at worst is fragmented care.  Often, the personnel in physicians' offices who actually do the cerumen management are much less well-trained to perform cerumen management than aduiologists.  They are responsible to learn and perform various procedures on the whole body, whereas audiologists are limited to and specialize in the ears only. Therefore, audiologists, in general are much better prepared and have much more experience working with ears than health professionals who must divide their time and experience over the entire body.  Also, frequently physicians refer their patients to audiologists for cerumen management because of the audiologist's expertise and experience in this area.  And so, I would submit that audiologists are the profession of choice to remove impacted cerumen and cerumen which covers more than 25% of the view of the tympanic membrane.

Please consider the concerns mentioned above and remove Section C, Items 2, 7, 10, and 11 as contraindications for audiologists performing cerumen management.

Elizabeth C. Anderson, Au.D.

Doctor of Audiology

My name is Kim Fisher and I am an owner of Richmond Hearing Doctors, PLLC.  I have been a licensed audiologist in Virginia since 2000 and have practiced audiology at VCU Health System and in private practice.  I primarily work with hearing aid patients and come across cerumen on a daily basis.  In order to provide effective and efficient hearing health care, it is necessary to provide cerumen management.  Audiologists are highly trained and skilled practitioners who can safely remove cerumen or identify when a referral to a physician is warranted.  The emergency  regulations are excessively restrictive and will result in unnecessary, multiple office visits for patients, not to mention a delay in care when they are seeking out a simple hearing evaluation and/or hearing aid maintenance.

Like many of my colleagues have already stated, I am frustrated with the limitations put on audiolgists in the Commonwealth.  I travel to retirement communities to provide convenient hearing health care to patients who are unable to easily leave their facility for appointments and the majority of these patients have contraindications listed on the emergency regulations.  It certainly isn't uncommon for me to see patients with diabetes, no hearing in one ear or find less than 25% of the tympanic membrane visible.  Instead of safely and effectively removing the cerumen myself, arrangements must be made to transport the patient to a physician who may or may not provide cerumen management or may not have the proper tools to effectively remove cerumen.  It is not only unrealistic to transport all of these patients to an otolaryngologist's office, it certainly is not cost-effective.

As an audiolgist, I spend my day in the ear canal taking deep impressions, inserting and removing the Lyric (an extended wear device) and performing immittance measurements to determine the status of middle ear and tympanic membrane function.  It doesn't make sense to restrict my ability to remove cerumen from only the outer 1/3 of the canal when I need access to the entire ear canal to perform other procedures.  It is unnecessary to list any contraindications that prevent me from using my training to identify when a referral is warranted.

I urge you to revise the regulations as soon as possible.  Thank you for your time and consideration.

Kim Fisher, M.A., FAAA

The  7 audiologists in our practice are in agreement with the previously submitted comments regarding the proposed excessive regulations regarding cerumen management by audiologists.

Under Definitions, Section B.  This rule indicating  that an audiologist can only remove cerumen in the outer 1/3 of the external canal is inappropriately restrictive since audiologists have extensive training in making earmolds and placing impression materials to the 2nd bend in the canal.

The contraindications listed in Section C are excessive:

These litmus tests for contraindication would require the audiologist to get out the regulations each time before proceeding with a simple cerumen management procedure.  Licensed audiologists trained in cerumen management are certainly qualified to judge whether they can successfuly remove cerumen or whether the patient needs to be referred to ENT for this procedure.  The board need not legislate and/or itemize these  contraindications.

Section D:  Why should the audiologist be required to have written consent from the patient  for cerumen removal?  If the audiologist has the appropriate training, this procedure is no more invasive than other audiological procedures which do not require written consent. 

Respectfully submitted:

Danny W. Gnewikow, Ph.D. Audiologist, FAAA, CCC

Nancy V. Bradsher, Au.D., Audiologist, FAAA, CCC

Lauren B. Stone, Au.D., Audiologist, FAAA, CCC

Kelly M. Camarda, M.Ed., Audiologist, FAAA, CCC

Kara M. Martin, Au.D., Audiologist, FAAA, CCC

Hope A. Middlemas, B.S. Provisional Audiologist, and 2015 Doctorial candidate

Lisa M. Schultz, B.A., Provisional Audiologist, and 2015 Doctorial candidate

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