As of August 2022, the FDA issued a final rule that establishes a new category of hearing aids.
These are Over The Counter (OTC) Hearing Aids. This ruling is intended to reduce the financial
burden of prescription hearing aids and to make hearing technology more accessible to
consumers.

OTC hearing aids are for adult patients with perceived mild to moderate hearing loss. They are
currently available or will be available soon in a variety of retail markets. Even though OTC
hearing aids are now available, there are some reasons they may not be the best choice for every
individual. An OTC hearing aid is not an appropriate option for individuals with hearing
thresholds beyond the mild to moderate hearing loss range. It is strongly recommended that any
individual considering purchase of OTC hearing aids have their hearing tested by an audiologist
first in order to determine if their hearing levels are appropriate for OTC devices.
Perceived hearing difficulties may be a sign of a temporary hearing issue like occluding wax in
the ears which can be removed by an audiologist. Additionally, OTC hearing aids are not
appropriate solutions for those with a perceived difference in hearing between the right and left
ears, a sudden change or worsening in hearing, ringing or roaring in one or both ears (tinnitus),
dizziness or vertigo, or pain and/or drainage from the ears.

Hearing aids are medical devices. Treatment may be appropriate and cost-effective with OTC
hearing aids, but without evaluation by a hearing healthcare professional, it could also cause a
person to miss out on proper hearing care. Audiologists can evaluate and diagnose the cause and
degree of a person’s hearing loss. In addition, audiologists can appropriately and safely select,
carefully fit, and tune hearing aids to best meet an individual’s listening goals. The involvement
of a hearing healthcare professional allows for routine follow-up care and troubleshooting to
ensure individual satisfaction and proper function over time.

The Delaware Speech and Hearing Center encourages all consumers to educate themselves,
contemplate whether OTC hearing aids will fully address their needs, and consider scheduling a
full hearing evaluation before moving forward with the treatment of their hearing needs. Please call
740-369-3650 or email contact@delawareshc.org for more information or to schedule a hearing
consultation appointment.