By Nichole Kingham, AuD
On August 16, 2022, the long-awaited guidance for OTC (over-the-counter) hearing aids was announced by the FDA. As soon as October 2022, hearing aids will be sold directly to consumers in stores or online without a medical exam or fitting by an audiologist. The new rule applies to hearing aids for adults 18 and older with “perceived” mild to moderate hearing loss. Hearing aids for children, those with other medical conditions such as sudden hearing loss or hearing loss in just one ear, as well as hearing aids for those with severe to profound hearing loss would still require a prescription device, fitted by an audiologist or licensed hearing aid dispenser.
The public comment period, which ended in January 2022, garnered over 1000 public comments to the initial proposed rule. In their announcement on the finalized rule, the FDA explained a few changes made based on those comments:
“The final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood. The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.”
Although these changes are a move in the right direction, audiologists are still concerned with several key issues. One is that t-coils and connection to accessories are not likely to be available in OTC hearing aids. Another is that the rule doesn’t require OTCs to be returnable. Additionally, state licensure laws still require hearing aids to be dispensed by a licensed hearing aid dispenser or audiologist with a diagnostic hearing test and not by support staff, such as an Audiology Assistant. This may make providing OTC hearing aids inside an audiology clinic cost prohibitive, leading clinicians to decide to not service or sell such devices, leaving consumers without the expert advice that has been proven to be behind successful outcomes with hearing aids.
In fact, a 2017 study conducted by Catherine Palmer, AuD, Director of Audiology at the University of Pittsburgh and the head of the OTC Taskforce for the American Academy of Audiology showed that prescription hearing aids have the highest user satisfaction. The study tested outcomes when adults, aged 55 to 79 years old with mild-to-moderate hearing loss chose between three pre-programmed digital mini behind-the-ear hearing aids, without the help of an audiologist. The volunteers paid for the hearing aids upfront and got their money back if they chose to return them. The results? Fifty-five percent wanted to keep them. Here’s the kicker: 90% of the participants tried more than one hearing aid before they found one they thought worked well. But close to three-quarters picked the wrong hearing aids based on their audiograms. And, although they saw a video and received handouts, 20% asked for extra help with how to use them.
In that same study, a comparison group was fitted by audiologists and 81% of the participants wanted to keep their hearing aids after completing the entire fitting process, which included the completion of Real Ear Measures—the only true way to show that hearing aids are fitted correctly to your hearing loss.
For those who chose hearing aids without the assistance of an audiologist who then chose not to keep the hearing aids, Dr. Palmer’s researchers offered the opportunity to work with an audiologist with properly fitted hearing aids for one month. Of 10 people who had chosen to not keep their self-fit hearing aids, six decided to keep hearing aids after working with an audiologist.
For members of Hearing Loss Association of America, the benefit of working with an audiologist is well known. HLAA members are aware that the ear is a complicated organ. Fitting hearing aids is not like fitting glasses and OTC hearing aids will not find the same success as “reader” glasses. In addition, an online hearing test cannot diagnose diseases of the ear or catch complicated hearing losses. The audiologist’s concern is that professional services, including appropriate hearing testing, appropriate hearing aid style and technology choice, necessary counseling on assistive devices including t-coils and accessories, and the critical long-term aftercare for hearing aids will not be available to OTC users. We must all continue to educate consumers on the benefit of properly fit hearing aids and tell them to see an audiologist!
Dr. Kingham is a Board Certified Audiologist and the owner of Eastside Audiology in Issaquah, Washington. She is also the Chief Education Officer for Audiology Academy, an online Audiology training platform for audiologists and their support staff. She is the mother of eight, grandmother of one, and a cancer survivor. She loves her blue Jeep and spends her free time with her family “jeeping” in the mountains.