This final rule will generate potential benefits in the form of 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. We estimate consumer benefits of between $6 M (million) and $147 M per year based on fifth and ninety-fifth percentile Monte Carlo results with a mean of $63 M per year. Because this is an annual benefit, the annualized benefits are the same at 3 percent and 7 percent discount rates. 

The final rule will also generate 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 (SOPs) in response to the rule. We estimate annualized cost of between $1 M and $2 M with a mean of $1 M per year at both 3 percent and 7 percent discount rates.

This final rule may also generate potential benefits and costs for consumers, if any, who currently buy hearings aids online, not bundled with professional services, but who find that the hearing aids meeting the OTC requirements, such as output limits, do not suit their purposes and thus need to move to prescription devices with professional input. The potential cost involves the need to buy the professional services required for the prescription to obtain a hearing aid they can currently obtain without such services, while the potential benefit involves the avoidance of health risks and issues the professional services are meant to address for consumers who require prescription hearing aids. We do not have sufficient information to quantify this potential tradeoff. We also lack data to quantify costs to any consumers who may currently buy particular brands or models of hearing aids online, that are not bundled with professional services and do not meet the OTC requirements, who would reject alternative prescription or OTC hearing aids that may become available, including those sold online and in brick and mortar shops, and who prefer to wait for their preferred brand or model to either become available as a prescription hearing aid or be redesigned to meet OTC requirements and offered as an OTC device. Such consumers may face some delay in getting their preferred hearing aids. 

Combining benefits and costs, we estimate annualized net benefits of between $5 M and $145 M per year based on the fifth and ninety-fifth Monte Carlo percentile results with a mean of $62 M per year at both 3 percent and 7 percent discount rate. 

Regulatory Impact Analysis

Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Regulatory Impact Analysis (PDF - 319KB) 

Federal Register: 87 FR 50698, August 17, 2022

Docket: FDA-2021-N-0555