Why Release the OTC Hearing Aid and Rules 2022

Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is finalizing rules to address some of these concerns.

The FDA created two categories of hearing aids. The first category is for prescribed hearing aids that require professional audiology services. The second category is OTC hearing aids, some of which may not fit well in the ear. The FDA approved the sale of OTC hearing aids for people with perceived mild to moderate hearing loss.

FDA is establishing a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids are intended to address perceived mild to moderate hearing loss in people aged 18 or older. Along with the OTC category, we are finalizing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the new OTC category. We have determined that the requirements set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.

This rulemaking also affects other regulations that applied to hearing aids. FDA had established device restrictions for hearing aids that included labeling requirements as well as conditions for sale. We are removing these device restrictions for hearing aids and establishing a new regulation for prescription hearing aid labeling. Further, FDA had by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are removing the regulations codifying these decisions and establishing other regulations clarifying some of the effects of statutory preemption under FDARA.

This rule to establish OTC hearing aids and align other regulations generates potential cost savings for consumers with perceived mild to moderate hearing impairment who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance but who are currently unable to buy such products online because of State regulations or because they do not shop online. This rule also generates costs for hearing aid manufacturers for changing labeling of existing hearing aids as well as for reading the rule and revising internal standard operating procedures in response to the rule. We estimate benefits of between $6 million and $147 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $63 million per year. We estimate annualized costs of between $1 million and $2 million per year based on 5th and 95th percentile Monte Carlo results with a mean of $1 million per year. Combining benefits and costs, we used Monte Carlo analysis to estimate annualized net benefits of between $5 million and $145 million per year based on the 5th and 95th Monte Carlo percentile results with a mean of $62 million per year at both 3 percent and 7 percent discount rates.

The FDA’s new regulations for hearing aids are good for consumers. Among the protections in the regulations:

 [1] Out of a concern for safety, the FDA lowered the maximum volume of OTC hearing aids.

 [2] In-the-ear OTC hearing aids must be at least 10 millimeters from the eardrum to reduce the chance that injury to the eardrum will happen.

 [3] OTC hearing aids must have a user-friendly volume adjustment.

 [4] Hearing aid labeling must be simplified to make it easier for consumers to understand how to use their hearing aids safely and effectively; for example, recharging batteries, controlling volume, and best ways to clean the hearing aid.