Stakeholder Comments on Proposed FDA Rule

Stakeholders Comment on FDA’s Proposed OTC Hearing Aid Rule

Even short periods of excessively loud sound can leave lasting damage to a person's hearing. This is why adequate amplification parameters are needed to protect Americans' long-term hearing. As currently written, the FDA's proposed OTC Hearing Aid Rule allows amplification in OTC hearing aids of up to 120 decibels (dB), about the noise level of a chainsaw. The overwhelming consensus from hearing industry stakeholders is that this must change. Patient safety must be the priority for all hearing aids.

Ninety-one hearing organizations submitted formal comments to the FDA expressing concern that the proposed 120 dB maximum output limit and omission of a gain requirement will put patient safety at risk.

See below for what some of them said:

American Academy of Otolaryngology - Head and Neck Surgery:

"The AAO-HNS feels that this maximum is too high, and instead recommends that the output maximum should be no greater than the 110 dB in sound pressure level (SPL). For patients with mild to moderate sensorineural hearing loss (SNHL) this level should be more than adequate to provide benefit. Limiting output will limit the potential of noise-induced SNHL. Our concern is that there will be a percentage of patients who purchase these devices to improve hearing to a better than normal level, but who instead will be risking damage similar to that which is caused by those who listen to earbuds at excessive volumes. The AAO-HNS believes that these devices should have a maximum twenty-five DB gain limitation. [E]excessive gain can result in noise-induces hearing loss. Consumers purchasing these products without professional advice and fitting will be aware of this."

We Hope the FDA will Listen Carefully and Put Patient Safety First.