I am satisfied with the proposed changes to the regulation. 

Although the current emergency regulations are an improvement over the original regulations established nearly a year ago, I consider the regulations to be unusually and unnecessarily restrictive.  Specifically:

1. The audiologist conducting cerumen management must obtain informed written consent prior to performing cerumen management limited to the outer third of the external auditory canal.  I am not currently required to obtain informed written consent while placing foam and cotton blocks in the external canal--which regularly extend beyond the first and often the second bend of said canal.  I do seek verbal consent before placing any device, insert, earmold, or equipment in ANY patient's ear. 
2. Cerumen management is currently limited to debris that is located in the outer third or cartilagenous portion of the ear canal.  Yet, if I elect to use irrigation or water to move ear wax from the patient's canal, pressured water will naturally move against the tympanic membrane.  It is permissible for water to pass beyond the outer third of the ear canal but hand held devices such as suction or curettes may not?
3. Manditory referral of patients to other health care professionals for cerumen management has created unneccessary medical and fiscal hardship to at least six of my patients.  One hospitalized patient with severe hearing loss had to wait six weeks for replacement of hearing aids lost while in hospital.  Due to impacted ear canals, I could not make earmold impressions required for hearing aid replacement and (s)he attended  four weeks of inpatient rehabilitation was compromised by her untreated cerumen management (and unremedied hearing loss).  Three other patients had to wait over a month for cerumen removal that I had previously provided.  Two other patients stated that 'my family doctor told his nurse to remove the wax from my ears; she used water to push the wax out and it hurt so much more than when you cleaned my ears.'  Ironically, when the later two patients returned to my office, otoscopic inspection revealed much significant non impacted wax in the lateral portion of each ear canal.    The emergency regulations force me to refer my patients out for cerumen managment to health care professionals who are not 'certified' for cerumen managment.  Does this constitute an improvement protection of the citizens of Virginia?  I think not. 
4. In its present form, the Emergency Regulations require me to 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. 

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 continue to revise these Regulations to be less restrictive to audiologists performing safe cerumen management. 

Thank you.

Lorraine (Lori) Klein Gardner, Au.D.

Doctor of Audiology--Owner, Hear Virginia

Richmond, Virginia

The new regulation still requires Audiologists receive training and certification on how to safely remove cerumen.  Audiologists are well aware of how to identify when a medical referral to an ENT physician is warranted and of course the regulations prevent audiologists from removing wax when there are medical contraindications. I agree with the written contraindications listed in the newly written/revised regulation. However I disagree with the requirement of informed consent and the requirement that cerumen should only be removed from the outer 1/3 of the canal.  These 2 aspects of the regulation should be reconsidered for the following reasons.

1.     There should no longer be the same level of concern for the “safety of public” since the new training requirements provide audiologists with the appropriate skill set to safely remove non-impacted wax from the entire ear canal using 3 types of instrumentation.  Although the training program noted that currently, in Virginia, audiologists are being limited to the outer 1/3 of the canal, the training covered how to safely remove cerumen from the ENTIRE canal when medical contraindications are not present. If an audiologist doesn’t feel comfortable with their own skill level, they certainly should not venture beyond the outer 1/3, but audiologists who have the skills and access to appropriate instrumentation should not be limited.

2.     Obtaining informed consent on ALL patients for even the smallest amount of cerumen, especially given the current regulation requires audiologists to stay in the outer 1/3 of the canal, creates an undue burden on the audiologist and the patient. This is especially true when patients cannot authorize care for themselves. Many patients are going without appropriate care and cannot use their hearing aids because the legal requirement for obtaining an advanced directive takes an excessive amount of time and effort.

3.     Informed consent is not required for deep ear mold impressions, even though oto-blocks must be placed beyond the 2nd bend. The level of danger to the public in removing wax, especially from the outer 1/3, simply does not warrant SIGNED informed consent.

4.     The AMA recently issued clarification on the only CPT Code for removal of cerumen. A noteworthy revision of this code is that, physicians must use some type of instrumentation and may not remove cerumen solely by irrigation or lavage.  This follows the guidance given to AMA from American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) many years ago.  Since primary care physicians, nurses often only have access to irrigation or lavage, and do not have access to other instrumentation; they are now turning away patients who need to their ears cleaned.  What about the small stuff? 

The reality for those of us practicing clinical audiology in a variety of settings is that many patients are going without appropriate care for weeks and sometimes even months at a time.  I can certainly understand the need for informed consent when the cerumen is impacted and/or it is found to be beyond the lateral 1/3 of the canal.  But under the newly written regulation, Audiologists are not allowed to remove cerumen under either of those conditions; therefore it seems excessive to require informed consent to simply remove even the smallest amount of cerumen from the outer 1/3 of the canal.  

It is important to understand many Audiologists often need to remove small amounts of wax because the wax is simply making a patient’s hearing aid less effective, they need to take an earmold impression and/or they need to complete audiological testing.  Many audiologists regularly see patients in residential retirement communities who do not have a POA who accompany them to their visit.  The reason they are in residential care is they can’t sign documents and/or are often difficult to transport off sight.  Despite obtaining and degree in audiology, attending a special hands-on training course and being very familiar with ear canals, audiologists still can not remove even a smallest amount of wax without getting a signed informed consent.  Informed consent only makes sense when cerumen is impacted or beyond the 1/3, so until the Board broadens the definition to allow audiologists access to the entire canal, the informed consent requirement should be removed from the regulation.

Thank you for your consideration on this final matter.  Audiologists are highly trained and capable of identifying those how need an ENT physician to be involved.  These limitations are significantly impacting many patients access to appropriate care.

Leah Ball, Au.D.

Clinical Audiologist/Owner Richmond Hearing Doctors, PLLC