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