On August 16, the FDA released its final rule to establish a new device category for over-the- counter (OTC) hearing aids. The AAO-HNS released this statement shortly after the rule’s release. By way of background, the FDA Reauthorization Act of 2017 (FDARA) directed the FDA to establish a category of OTC hearing aids through rulemaking, and mandated that FDA establish various requirements for this category of devices. The agency’s creation of a new device category of OTC hearing aids enables consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. Hearing aids for more severe hearing loss or for users younger than age 18 remain prescription devices.
Following publication of the agency’s proposed rule on OTC hearing aids in October of 2021, the FDA received more than 1,000 comments, including those submitted by the Academy. Below is a high-level summary of the most impactful elements of the final rule for otolaryngologist-head and neck surgeons. The Academy has also prepared a series of helpful resources and FAQs for patients. The final rule is scheduled to take effect on October 17.
Scope and definitions
In this rule, FDA made multiple related changes to the overall regulatory framework for hearing aids to harmonize existing regulations with the OTC category while continuing to provide reasonable assurance of safety and effectiveness. The FDA does not believe that objective measurements of hearing impairment are necessary to provide reasonable assurances of safety and effectiveness. The final rule asserts that even with an audiogram, when tailoring the hearing aid, a licensed person will seek the user’s perception to help make further adjustments. Of note, the FDA agrees that “ear-nose-throat doctor” and “ENT” is a better descriptor than “ear specialist.”
Output limits
The FDA finalized a general output limit of 111 decibels of sound pressure level (dB SPL), with 117 dB SPL allowable for devices while input-controlled compression is activated. While the Academy suggested an output limit of 110 dB SPL, the FDA believes that the general limit of 111 dB SPL balances safety and effectiveness without sacrificing either. The agency asserts that lowering the output limit even further would begin excluding intended users without meaningful improvements in safety.
Input controlled compression automatically reduces a device’s output and helps prevent the device from continuously performing at its output limit. As a result, the FDA finalized a higher conditional limit of 117 dB SPL for these devices, in order to maximize the available dynamic range for OTC hearing aids while still providing reasonable assurance of safety and effectiveness.
Gain limit
The FDA is not finalizing a separate gain limit. By reducing the ability to adequately amplify soft sound inputs, a gain limit could decrease device effectiveness and user satisfaction. The FDA believes that the output limits as finalized will sufficiently limit device output. The decision to not include a separate gain limit allows manufacturers the flexibility to design their devices to balance the required output limits with the amplification needs of the intended user population.
Design requirements
To minimize the risk of injury to the tympanic membrane and the skin of the bony portion of the ear canal, the FDA has finalized that the innermost component of the device must be setback a minimum of 10mm from the eardrum. This fixed insertion depth limit relative to the expected distance from the eardrum will allow for individual anatomic variability without unduly limiting effectiveness. This is a revision from the proposed rule where an anatomical landmark (the bony cartilaginous junction) was proposed as the measure of insertion depth. This proposal was deemed not practical based on the uncertainties stemming from anatomical variability and insertion depth measurement.
For adults, the average length of the ear canal has been estimated to be 25 mm. While the FDA is not finalizing a fixed length design requirement, manufacturers may generally assume that the maximum insertion depth of a hearing aid designed with a 10 mm setback will be approximately 15 mm. The FDA recognizes that this design requirement may result in an actual setback of somewhat less than 10 mm in users with shorter than average ear canals. However, they believe that the limit is conservative enough to ensure safety even in these cases.
Conditions for sale
OTC hearing aids cannot be sold to individuals under the age of 18, but the FDA is not requiring age verification. Labeling requirements must advise that individuals under the age of 18 should consult with a doctor and refrain from using OTC hearing aids. Prescription hearing aid sales will be subject to the requirements in § 801.109 (21 CFR 801.109), including that they be sold only to or on the prescription or other order of a practitioner licensed by law to prescribe the devices.
Labeling
The FDA finalized labeling requirements to try to help consumers recognize perceived mild to moderate hearing impairment. Additional labeling requirements will help users understand whether a device is suitable based on their perceptions, establish realistic expectations for hearing aid use, and suggest when to obtain professional assistance before and after purchase.
The final rule changes the term “ear specialist” to “ear-nose-throat doctor” or “ENT” based on concerns that the term “ear specialist”, as utilized throughout the proposal, was not specific enough. An “ear specialist” could imply a non-physician, such as an audiologist or a hearing aid dispenser. As such, using the term “ear specialist” in labeling may confuse or inadvertently mislead hearing aid users.
The FDA agrees that plain language will help users understand information and finalized improved phrasing throughout the labeling to make it more understandable for hearing aid users. This includes a listing of a “red flag” condition, a sign or symptom that should prompt a consultation with a doctor, preferably an ear-nose-throat doctor.
New Prescription Hearing Aid Category
Under previous law and regulations, the FDA allowed a prospective hearing aid user 18 or older to waive the requirement for a medical evaluation prior to obtaining a hearing aid. The final rule notes that, in some circumstances, requirements on prescription hearing aids once the final rule is in effect may be more stringent than under former regulation. Consistent with the proposed rule, the FDA does not intend to enforce the medical evaluation, waiver, or recordkeeping requirements for prospective purchasers who are 18 or older. However, any hearing aid that meets the definition of a prescription hearing aid will be subject to requirements for prescription devices. That is, such devices may be sold only to or on the prescription of a physician or other order of a licensed practitioner.
States, not FDA, generally determine the licensing requirements for practitioners to use or order the use of a prescription device. Thus, States may, for example, require that prescription hearing aids be ordered by physicians or audiologists, which may involve a medical or audiological evaluation of the prospective user, including someone who is 18 or older.
OTC category and self-fitting air-conduction hearing aid classification
The FDA is not requiring OTC hearing aids to be self-fitting devices. However, to have reasonable assurance of safety and effectiveness, OTC hearing aids must be controllable by the user and customizable to the user’s hearing needs. To be customizable, the user must be able to access and select the output characteristics. This includes the ability to select the frequency-dependent output profile and the output volume.
Return Policy
The FDA is not establishing post-sale requirements of OTC hearing aids including requirements that manufacturers or sellers accept returns for a certain minimum period, warrant certain features or components for a given period, guarantee products or services in some way, and/or provide a minimum rescission period. The FDA does not believe that these post-sale requirements impact the safety and effectiveness for OTC hearing aids. The agency did finalize a requirement for OTC hearing aid labeling to provide notice of a manufacturer’s return policy. The FDA acknowledges in the Final Rule that there may be other Federal laws, administered by other agencies, that provide these types of consumer protection.
State vs. Federal Law Preemption
Prior to the establishment of a category for OTC hearing aids, the FDA had by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. In the final rule, the FDA removes the regulations codifying these decisions and establishing other regulations clarifying some of the effects of statutory preemption under FDARA. 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.
With respect to OTC hearing aids, the FDARA preemption provision preempts State and local requirements specifically related to hearing products that would restrict or interfere with commercial activity involving OTC hearing aids, and that are different from, in addition to, or otherwise not identical to regulations issued under FDARA. For State or local requirements that tie consumer protections to licensing requirements, the consumer protections are not necessarily preempted. That is, State or local governments cannot require persons engaged in commercial activity involving OTC hearing aids to undertake special licensing or equivalent activities solely on that basis. However, such persons who voluntarily identify as a licensed person would be subject to corresponding State or local requirements for such licensed persons, including consumer protection requirements, to the extent that the State or local requirements do not restrict or interfere with commercial activity involving OTC hearing aids
As a result, if a State establishes or continues in effect a requirement that, for example, people younger than 18 must have a medical evaluation by an ear-nose-throat doctor to obtain a prescription hearing aid, then that requirement would, as a general matter, no longer be “different from, or in addition to,” the examination and waiver requirements that we are repealing. Similarly, a State could establish or continue in effect a requirement, for example, that a licensed hearing instrument specialist refer an adult prescription hearing aid candidate for a medical examination if the specialist observes a Red Flag condition. However, a State could not establish or continue in effect such a referral requirement for OTC hearing aids.
