Hearing Health Guide
Definition
Over-the-counter (OTC) hearing aids are a category of hearing devices established by the FDA in October 2022 under the Over-the-Counter Hearing Aid Act. Adults 18 and older with perceived mild to moderate hearing loss can purchase, fit, and adjust OTC hearing aids without a medical evaluation, a prescription, or a visit to a licensed audiologist or hearing instrument specialist.
Prior to October 2022, all hearing aids in the United States required purchase through a licensed audiologist or hearing instrument specialist, following a professional fitting and evaluation. The OTC Hearing Aid Act of 2017 directed the FDA to create a new OTC category, which took effect in October 2022.
The rule created two classes of hearing aids: prescription hearing aids (for all degrees of loss, fitted by a licensed professional) and OTC hearing aids (for adults with perceived mild to moderate loss, self-fitting). Think of it like eyeglasses: reading glasses are available OTC for common refractive issues, while complex prescriptions require an optometrist.
The FDA OTC category is for adults 18+ who believe they have mild to moderate hearing difficulty. This includes people who frequently ask others to repeat themselves, struggle in noisy environments, or need the TV at high volume, but who have not had a clinical diagnosis of severe or profound loss.
OTC aids are not appropriate for children, anyone with sudden or asymmetric hearing loss, anyone with a history of ear infections, ear drainage, ear deformity, or severe to profound hearing loss. These cases require professional evaluation.
Prescription hearing aids are fit by an audiologist who measures your exact hearing thresholds across frequencies and programs the device precisely to your audiogram. They can address a wider range of hearing loss, including severe and profound. They typically cost $3,000-$7,000 per pair including professional services.
OTC hearing aids are self-fit using a smartphone app. They offer adjustable amplification profiles but without the precision programming of a professionally fitted prescription device. They typically cost $200-$1,500 per pair. For mild to moderate high-frequency loss, the outcome difference between OTC and prescription aids can be minimal. For complex loss patterns, professional fitting is strongly preferred.
Common Questions
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