A statement from Commissioner Jace Wolfe, Ph.D., CCC-A on over-the-counter hearing aids

Dr. Jace Wolfe is the chief of audiology and research at Hearts for Hearing in Oklahoma City. He provides clinical services for children and adults with hearing loss and is actively engaged in research. He is an author and adjunct professor in the audiology department at the University of Oklahoma Health Sciences Center and Salus University in Elkins Park, Pennsylvania. He is vice chair of the Commission for Rehabilitation Services, which governs Oklahoma Department of Rehabilitation Services.

OKLAHOMA CITY  — This week, the United Stated Food and Drug Administration (FDA) issued a final rule that establishes a new category of over-the-counter (OTC) hearing aids. These devices may be purchased without a prescription from an audiologist or physician, and they are intended for people with mild to moderate hearing loss. It is estimated that almost 38 million Americans have hearing loss that negatively impacts their communication in daily situations. Research has shown hearing loss is linked to overall health including an increase in the likelihood of dementia and cognitive decline, social isolation and depression, diabetes, and balance difficulties and falls. Preliminary findings of recent research studies have suggested the use of hearing aids may improve overall health, and in particular, may serve to promote cognitive fitness by the provision of greater stimulation of the auditory centers of the brain and by keeping individuals with hearing loss engaged in social, recreational, and occupational activities.

Of the 38 million Americans with significant hearing loss, only about 8 million use hearing aids or other hearing assistive technology. I am hopeful that the availability of OTC hearing aids will raise awareness of the importance of good hearing and will improve access to hearing technology for individuals with mild to moderate hearing loss. It is important that the general public realizes the complexities that are often associated with hearing loss. Hearing loss, hearing abilities, and communication needs often vary considerably from one person to the next. Most individuals with hearing problems will be best served by having their hearing evaluated by a licensed audiologist. The cost of an audiological evaluation is often covered by insurance including Medicaid and Medicare. Audiologists are able to determine how an individual’s hearing loss varies across the speech frequency range, evaluate the unique hearing and communication needs of the individual, and inform the individual of the pros and cons of various interventions including OTC and prescription hearing aids, aural rehabilitation/therapy, constructive compensatory strategies, implantable hearing technologies, hearing assistive technologies, and the need for referral to a physician for medical evaluation and management.

It should be noted that prescription hearing aids are often available at prices that are similar to, or sometimes less than, OTC hearing aids. Prescription hearing aids are selected and programmed to meet an individual’s unique needs, and the audiologist can complete verification measures to ensure the hearing aids are set to optimize audibility for the sounds an individual with hearing loss may miss without hearing technology. Moreover, research has indicated that many people who obtained OTC hearing aids reported a need for audiological support to maximize their comfort with and benefit from these technologies.

Much is still unknown about the level of technology that will be present in OTC hearing aids. It is likely that OTC hearing aid technology will evolve and improve over time. There is uncertainty for how individuals with hearing loss will evaluate their hearing abilities and adjust OTC hearing aids to meet their own unique needs. Once again, a licensed audiologist can identify the unique needs of an individual and complete testing to determine whether an OTC hearing aid is appropriate for that person’s needs.       

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