The FDA requires a statement of a doctor’s exam before the sale of hearing aids for children (younger than 18 years of age). But, the agency is not requiring measurements of hearing loss to establish prospective users’ qualification, prior to purchasing OTC hearing aids.
To broaden access to hearing aids, the FDA is proposing a new category of OTC hearing aids that could be purchased in the store or online without seeing a physician for an exam or an audiologist for help with fitting.
Hearing aids are devices intended for human use, and are subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) amended by the FDA Reauthorization Act of 2017 (FDARA).
Currently, air-conduction hearing aids are generally either class I or class II medical devices. Furthermore, hearing aids and Personal Sound Amplification Products (PSAPs) emit electronic product radiation and are electronic products, meaning they are subject to the electronic product radiation control requirements.
Behind-the-ear (BTE) aids: BTE hearing aids are generally the largest hearing aid style. A plastic case containing most of the electronics sits behind the ear and is connected to an earmold that fits in the ear canal. BTE hearing aids can be used by people of all ages. The style is often chosen for young children because it can be adapted as they grow.
Receiver-in-the-canal (RIC) aids: RIC (or mini receiver-in-the-ear; mini RITE) hearing aids sit behind the ear but are typically smaller than a BTE. The RIC hearing aid is attached to a tube housing a small wire with a dome-shaped tip at the end that rests in the ear canal (in some cases, earmolds are used). The RIC design allows more of the ear canal to remain open and is less visible than the BTE style.
In-the-ear (ITE) aids: This hearing aid sits completely in the outer ear (the “bowl” of the ear). All the hearing aid electronics are housed in a custom-fit shell.
In-the-canal (ITC) aids and completely-in-the-canal (CIC) aids: These are the smallest hearing aids currently available. The electronics are contained in a small custom-fit shell that fits partly or completely into the ear canal. Some people may like them because they are less noticeable while other people may find them harder to handle.