OTC Hearing Aid Rules

Unpublished version posted 10/19/2021

Main points:

State & Local Regs take back seat

Under FDARA section 709(b)(4), the OTC Hearing Aid Controls that are the subject of this rulemaking, proposed § 800.30, if finalized, would preempt any State or local requirement specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids, that is different from, in addition to, or otherwise not identical to, the OTC Hearing Aid Controls, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids.

There is a user app requirement

We are proposing to codify the requirement that an OTC hearing aid must include tools, tests, or software through which a lay user can control the device and customize it to the user’s hearing needs

Minimum bandwidth requirements

We believe that the proposed required frequency bandwidth, 250 Hz to 5 kHz, will ensure amplification of daily speech or other environmental sounds because almost all such sounds typically fall between these proposed lower and upper cutoff frequencies

Output limits of 115-120 SPL

We propose a maximum OSPL90 output level of 115 dB sound pressure level (SPL) as a general rule to balance consumer safety with device performance.However, we would permit a limit of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control (i.e., volume adjustment). This is because a user adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device’s limit. Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device’s limit, at any given moment