Sound amplifiers and OTC hearing aids: how the FDA tells them apart, and what each may claim

Products sold as “sound amplifiers” can sit next to over-the-counter (OTC) hearing aids in stores and online, and both make sound louder for the user. The Food and Drug Administration draws a firm line between them. An OTC hearing aid is a medical device for adults with perceived mild to moderate hearing loss. A personal sound amplification product, or PSAP, is consumer electronics meant for people with normal hearing who want to hear certain sounds better, such as birds or prey when hunting. PSAPs “are not alternatives to hearing aids,” the FDA's consumer page says. What puts a product on one side or the other is less its circuitry than what its seller claims.

Three categories, side by side

Hearing aids that do not meet the OTC requirements are prescription devices. The FDA's consumer page adds that, because PSAPs are regulated as consumer electronics rather than medical devices, they “may be more variable in terms of product quality” than hearing aids.

Why the claims matter more than the hardware

The FDA set out the distinction in a guidance document issued on August 17, 2022, alongside its rule creating the OTC category. It acknowledges that the technology of hearing aids and PSAPs “may be similar,” and says it looks instead at a product's intended use: the objective intent of those responsible for its labeling, which can show in written or spoken statements, in the product's design or in the circumstances of its distribution; the FDA may weigh any claims in its labeling, advertising and promotion.

A claim, stated or implied, that a product addresses, mitigates or improves hearing loss turns it into a device in the FDA's view, subject to the device rules and the specific hearing aid requirements. The guidance gives examples of claims or statements that would generally have that effect:

• Suggesting the product is for users with particular types or degrees of hearing loss.
• Suggesting it is for situations typically associated with hearing loss.
• Presenting it as an alternative to a hearing aid, for example as a cheaper option or for people not yet ready to buy hearing aids.
• Giving the user information to tune it to their hearing loss, such as hearing thresholds, or using a hearing aid fitting formula to match its output to the user's hearing loss.

The FDA's examples of situations where PSAPs are typically used include hunting, bird watching, listening to a distant speaker at a lecture, and picking up soft sounds, such as distant conversations, that are hard for people with normal hearing to catch.

What rules a PSAP does follow

Because a PSAP is not intended to diagnose, treat or mitigate disease or to affect the body's structure or function, it is not a device under the Federal Food, Drug, and Cosmetic Act. The guidance says there is no regulatory classification or product code for PSAPs, and no requirement for their makers to register with the FDA or list the products. They are not unregulated, though. As electronic products that emit sonic vibrations, PSAPs fall under the Radiation Control for Health and Safety Act of 1968, and their makers must report accidental radiation occurrences, report defects and take related measures, and repurchase, repair or replace products when those rules require it. In our reading, the absence of a product code means a PSAP will not show up in the FDA's device classification records the way a hearing aid does.

How to tell on the box

The 2022 rule gave buyers one visible signal. The principal display panel on an OTC hearing aid's package must bear the marks “OTC” and “hearing aid,” and sellers may offer a hearing aid over the counter only when its package carries them. The FDA said it agreed that telling devices from non-devices “can be an important interest” for buyers and makers.

It turned down two other requests from commenters on the rule. One asked it to write into the definition of a hearing aid that PSAPs are not hearing aids. The FDA declined, saying a product's name on its own would not ordinarily show its intended use, so the exclusion would not take a product out of device regulation if its labeling showed it was meant to compensate for hearing loss. Others asked that hearing aid labeling explain the differences between OTC aids, prescription aids and PSAPs. The FDA said that information “may be helpful to know” but was not necessary for the devices' safety and effectiveness, and noted, among other reasons, that it was issuing its guidance on the differences alongside the rule. What an OTC hearing aid itself must meet, from output limits to package warnings, is in our guide to the FDA's OTC hearing aid rules.

Where the rules stand

The August 2022 guidance replaced one from February 25, 2009, and followed drafts issued in 2013 and 2021. The FDA's guidance page, read on November 13, 2026, still lists it as final, and our search of the Federal Register that day found no FDA document on PSAPs published after August 2022. The FDA's consumer update and its page on other hearing devices carry content dates of May 4, 2023 and November 18, 2022.

The FDA's consumer page carries a reminder from Eric Mann, a senior adviser in the office responsible for hearing aids, that hearing loss “could be a sign of an easily treatable problem like built-up earwax or a more serious problem like a benign tumor on the hearing nerve,” and he advises seeing a doctor when hearing loss is progressing or comes with symptoms such as dizziness, ear pain or drainage. The FDA says OTC hearing aids must not be sold to anyone younger than 18, and that problems with a hearing aid can be reported to its MedWatch program.