ASHA Comments on Draft Regulations For Over-the-Counter Hearing Aids

Organization Points Out Public Safety Risks, Pre-Purchase Need for Audiologic Assessment

January 13, 2022

(Rockville, MD) Stressing the need for safety and for the pre-purchase of audiological assessment, the American Speech-Language-Hearing Association (ASHA) today submitted comments to the U.S. Food and Drug Administration (FDA) concerning draft regulations for over-the-counter (OTC) hearing aids, a new category of medical devices intended for persons with mild-to-moderate hearing loss. These OTC devices are expected to be available later this year.

“Hearing loss is a serious and complex medical condition that affects approximately 48 million Americans,” said ASHA 2022 President Judy Rudebusch Rich, EdD, CCC-SLP, BCS-CL.

 “It can have great impact on a person’s overall health, physical safety, and quality of life,” Rich said. “Consequently, we appreciate the opportunity to comment on the draft regulations. The final version of them will have a significant bearing on the lives of many.”

ASHA opened its comments recognizing positive aspects of the FDA’s proposed rule that align with the recommendations of a 2018 consensus paper that ASHA developed in collaboration with the Academy of Doctors of Audiology, American Academy of Audiology, and International Hearing Society. 

However, ASHA went on to urge the FDA to adopt several revisions that would strengthen and ensure “appropriate access, consumer protection, efficacy, and patient safety grounded in the most robust and up-to-date research from the field.”

Key recommendations were made in the following areas:

  • Maximum output level. “It is imperative to ensure the maximum output level of these devices is no greater than 110 decibels (dB) in sound pressure level (SPL),” ASHA commented. The association noted that the proposed regulations have higher output limits that do “not optimally align with the goal of protecting the consumer from the risk of hearing damage.”
  • Gain limit. ASHA recommended requiring a “full-on gain limit of 25 dB” in keeping with a calculation of gain for adults with mild-to-moderate hearing loss derived from the most widely used gain formula worldwide. Excessive gain is problematic for many reasons, ASHA explained, “including increasing an individual’s risk of noise-induced hearing loss, tinnitus, and loudness discomfort.” It added that a gain greater than 25 dB “will allow manufacturers to target individuals who do not meet OTC criteria, with greater degrees of hearing loss, who have more complex needs and are more likely to have additional medical conditions.”
  • Input compression and volume control. These features would serve to significantly reduce individuals’ risk of further hearing loss due to loud noise exposure. ASHA also called for the regulations to limit customization of earpieces to non-invasive procedures to prevent ear and hearing damage.
  • Outside-the-box labeling. ASHA recommended that labeling acknowledge the benefit of having an audiologic assessment prior to obtaining any type of hearing aid and adding a symptom of mild-to-moderate hearing loss —“able to hear well in a quiet place when people speak at a normal or slightly louder than normal level, but have difficulty following conversation in a noisy environment”—to the list of functional descriptors to “improve a user’s ability to self-determine device candidacy.” The organization cautioned: “If individuals with greater than a mild-to-moderate degree of hearing loss utilize OTC hearing devices and do not perceive benefit, they may become frustrated with their devices and either utilize them with incorrect settings or stop using them all together. In the absence of a federally regulated return policy, these individuals may be deterred from pursuing additional effort to treat hearing loss.”
  • Device category definition. ASHA urged the FDA to define OTC hearing aids more clearly so consumers can easily determine how the devices will differ from amplification devices for people with normal hearing and prescription hearing aids. It cited a Fall 2021 ASHA poll that revealed a significant lack of public knowledge about OTC hearing aids.

Other comments by ASHA included the following:

  • A suggestion to label OTCs as “self-fit” medical devices and make them available with tools, tests, or software that allow consumers to customize device output to their individual needs. The draft regulations are ambiguous, ASHA said, and do “not appear to explicitly require” control of output. ASHA said that the absence of that explicit requirement allows for the possibility that manufacturers will put devices on the market that permit users to control only the physical fit of their device—and not the output.
  • Concern about an estimation based on the proposed device specifications that approximately 90% of prescription hearing aids being fit currently could be re-labeled as OTC hearing aids. “Many of the prescription hearing aids audiologists fit are not appropriate for individuals with mild-to-moderate hearing loss without the involvement of an audiologist.”
  • A request for clarification from the FDA on the effect of the proposed regulations on the preemption of state laws or regulations requiring an audiological or medical evaluation before dispensing a prescription hearing aid. ASHA asked the FDA to provide examples “that would not be subject to preemption” under the draft regulations.

ASHA’s comments in full. [PDF]

About the American Speech-Language-Hearing Association (ASHA)
ASHA is the national professional, scientific, and credentialing association for 218,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students. Audiologists specialize in preventing and assessing hearing and balance disorders as well as providing audiologic treatment, including hearing aids. Speech-language pathologists (SLPs) identify, assess, and treat speech, language, and swallowing disorders.

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