The legislative backstory

The path to OTC hearing aids began with the Over-the-Counter Hearing Aid Act of 2017, passed as part of the FDA Reauthorization Act. The law directed the FDA to establish a regulatory category for OTC hearing aids within three years. After delays — including the COVID-19 pandemic — the FDA published a proposed rule in 2021 and finalized it in August 2022.

The rule was supported by a broad coalition including consumer advocates, hearing health researchers, and technology companies. The American Academy of Audiology and some audiologist groups expressed concerns about patient safety and the removal of professional oversight, but ultimately the rule was finalized largely as proposed.

Who the rule applies to

OTC hearing aids are legally defined as devices intended for adults 18 years of age and older who have perceived mild to moderate hearing impairment. The rule explicitly excludes:

• Children under 18 (prescription hearing aids remain required)
• Adults with severe or profound hearing loss
• Devices intended to treat hearing loss caused by a medical condition requiring professional attention

The FDA chose "perceived" mild to moderate loss deliberately — it allows self-assessment without requiring a professional audiogram. However, the labeling requirements (see below) are designed to help consumers identify when professional care is needed.

Output limits and safety requirements

The FDA established specific technical requirements to protect consumers from over-amplification:

• Maximum output limit: OTC hearing aids cannot exceed 117 dB SPL (sound pressure level) output. This is lower than the maximum allowed for prescription aids, which can go higher for severe/profound loss.
• Maximum gain limit: No more than 25 dB of gain in any frequency channel. This limits how much amplification the device can apply.
• Frequency range: Must cover at least 200 Hz to 5,000 Hz.
• Volume control: Must include a user-adjustable volume control.
• Acoustic coupling: Must include at least one means of acoustic coupling (eartip, dome, or earmold).

These limits are specifically designed to make OTC aids safe for self-fitting without professional oversight — they prevent the kind of over-amplification that could damage hearing.

Labeling requirements

OTC hearing aids must include specific labeling to help consumers make informed decisions. Required label elements include:

• A statement that the device is intended for adults 18+ with perceived mild to moderate hearing loss
• Instructions for use, including how to insert and remove the device
• A list of conditions that should prompt the consumer to see a doctor before using the device (the "red flag" conditions)
• Information about the return policy
• Contact information for the manufacturer

The "red flag" conditions

The FDA requires OTC hearing aid labels to advise consumers to consult a physician if they have any of the following:

• Visible deformity of the ear
• Fluid, pus, or blood from the ear in the past 90 days
• Sudden or rapidly progressive hearing loss in the past 90 days
• Acute or chronic dizziness
• Hearing loss in only one ear, or significantly different hearing in each ear
• Ear canal blockage (earwax or foreign body)
• Pain or discomfort in the ear
• Ringing or noises in only one ear

What the rule does NOT require

Notably, the FDA rule does not require:

• A hearing test before purchase
• A medical examination or waiver
• Audiologist involvement in fitting or follow-up
• A specific return policy duration (though many manufacturers offer 30–60 days)

The removal of the prior medical evaluation requirement was one of the most significant changes from the previous regulatory framework, which required either a physician examination or a signed waiver.

OTC hearing aids vs. PSAPs: the regulatory distinction

Personal Sound Amplification Products (PSAPs) are not hearing aids — they are consumer electronics not regulated by the FDA as medical devices. They are intended for people with normal hearing who want to amplify sounds in specific situations (hunting, birdwatching). OTC hearing aids are FDA-regulated Class II medical devices with specific safety and labeling requirements. This distinction matters: OTC hearing aids have been tested and cleared for safety and effectiveness; PSAPs have not.