Bose Seeks ‘Regulatory Clarity’ From FDA on OTC Hearing Aids

The Food and Drug Administration was right to propose setting a maximum output level of 115 dB of amplification on over-the-counter hearing aids, with a 120 dB maximum permitted on devices with a user-adjustable volume control, commented Bose in docket FDA-2021-N-0555 in the agency’s rulemaking to create a category of affordable OTC hearing aids for U.S. adults with mild to moderate hearing loss (see 2112060002). Tuesday was the deadline for comments.

Bose, the only major manufacturer whose rulemaking comments were posted in the docket by Wednesday afternoon, markets a line of “self-fitting” OTC hearing aids under the SoundControl brand, paired with Bose Hear, a "self-tuning" mobile app that Bose says is clinically proven to provide "audiologist-quality customization" for hearing-impaired adults. The company urged the FDA in its final rule to clarify the “distinction” between self-fitting OTC hearing aids and non-self-fitting OTC devices “to eliminate potential confusion for manufacturers and consumers.”

It’s “unclear” from the proposed rule what parameters and “methods of customization” could be present in an OTC hearing aid without rendering it with a “programming” function that could classify it as self-fitting, said Bose. “This is an important distinction.” Self-fitting hearing aids would be subject to “premarket notification and special controls” that wouldn't apply to OTC hearing aids that aren't self-fitting, it said. “Absent additional regulatory clarity on which attributes render hearing aids self-fitting, we are concerned there will be disparate regulatory oversight with respect to OTC hearing aids that provide similar customizable functions, because different manufacturers will reach different conclusions as to the appropriate regulatory classification for similar devices.”

The technical and performance parameters the FDA is proposing for OTC devices are generally in line with those of the Personal Sound Amplification Performance Criteria standard (ANSI/CTA-2051) approved by the American National Standards Institute and CTA in January 2017. The FDA’s proposed output limits “are intended to balance the risk of injuries from exposure to loud sounds when amplified by OTC hearing aids with the ability to provide effective amplification” for the hearing-impaired, said Bose. “The output limit is the most important electroacoustic specification for OTC devices. Getting this right has implications for safety and for the proportion of the intended user population that will be able to be usefully served with OTC hearing aids. Bose believes that FDA has made an appropriate, well-reasoned choice.”

Bose also “strongly agrees” with the FDA for resisting proposed limits on a device’s gain -- defined as the ratio between its output and input, said the company. “Relying solely on a maximum output limit is sufficient to assure reasonable safety and effectiveness,” it said. “Evidence from several published studies shows that when given control over their devices, users are unlikely to over-amplify. Instead, users tend to choose gain near (or somewhat below) values selected by a clinician.”

The company disagrees with audiologists who propose a 25 dB gain-limit requirement on OTC devices because “safety considerations do not support the imposition of gain limits for OTC hearing aids,” said the company. “We expect most OTC devices will have input-controlled compression. Therefore, maximum gains will occur with low level inputs, typically with speech at 50 dB.” Even with high gains at 50 dB input levels, “output levels will be insufficient to cause hearing damage,” it said.

The audio company agrees with the FDA that outside labeling on device packaging “should be understandable and help consumers answer the threshold question of whether they are suitable candidates for purchasing an OTC hearing aid,” it said. “Given the limited space available on small OTC hearing aid packaging, labeling on the outside packaging should be limited to essential pre-purchase information.”

Requiring manufacturers to disclose their return policies on the outside packaging of OTC hearing aids, as the FDA proposes, “could be confusing and even misleading to consumers purchasing the device from third party sellers with return policies that differ from the manufacturer’s return policy,” said Bose. Manufacturers “do not dictate” the return policies of third-party sellers, including retailers and e-commerce platforms, and those policies “can vary by seller and by jurisdiction, and are subject to change over time,” it said.

There can be “no straightforward way” for manufacturers to include these return policies on their product packaging, said Bose. Such packaging would need to be printed and applied case by case, “creating significant quality control challenges to avoid inaccurate labeling,” it said. Packaging mandates “would immeasurably complicate the product supply chain, increasing costs of production and distribution and ultimately consumer prices,” it said.

Bose recommends, alternatively, that the outside packaging include a statement advising consumers to consult with the seller about its return policies before buying the device, it said. This rule “will also have the effect of encouraging sellers to offer reasonable return policies, while eliminating confusion and allowing manufacturers and sellers to retain flexibility and control over their respective return policies without consuming undue packaging space,” it said.