Make listening Safe Workgroup Submits Comments on FDA OTC Hearing aid Rule

The World Health Organization's (WHO) "Make Listening Safe Workgroup" submitted a comment letter to the Food and Drug Administration (FDA) on its proposed rule establishing an over-the-counter (OTC) hearing aid category. The letter echoes concerns about the safety aspect of the proposal, particularly as it pertains to the dangerous output level proposed by FDA. 

The global hearing groups recognized the new OTC category as a "potentially good step" as it pertains to the WHO's recommendations on hearing care equity and access. However, the Workgroup cautions that the proposed output categories may result in hearing aid users doing further damage to their hearing. 

"We have concerns about the safety aspects of the current draft proposal, which proposes a limit of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control. With only this limit being required, OTC hearing aid users may be exposed to a significantly higher weekly sound dose than the 1.6 Pa²h (equivalent to 80 dBA exposure for 40 hours), as required in the ITU/WHO H.870 (''Guidelines for safe listening devices/systems'') and ITU H.871 (“Safe listening guidelines for personal sound amplifiers”) standards."

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