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Anticipated effect of FDA Final Rule on OTC Hearing Aids

on the future of hearing healthcare
emphasis on self-managed care


This report was prepared in observance of the



August 2022

Summary of Final Rule

  • Self identify mild to moderate hearing loss

  • Directly purchase hearing aids  - no medical exam/prescription/audiologist fitting

  • Self-select settings based on personal needs 

  • Know when to seek medical attention

  • Specified Quality standards

    • ​Safety and Effectiveness standards

    • Electroacoustics, Safety, Design, Labeling, Promotion

    • Output limit based on 'Occupational Noise Exposure’ CDC NIOSH

  • Low cost as the sale is direct to consumer​


Need for the Rule

The US has 37.5 M, age 18 and over,  with hearing troubles with a concerning increase in hearing loss particularly among young adults. A surprising 80% of those who could greatly benefit from using a hearing aid, do not use hearing aid. There are several reasons such as high cost, no direct access to hearing aids or simply not being aware of early signs of hearing loss.

The use of hearing aids has been linked to, among other health benefits, reductions in the incidence or severity of cognitive decline, depression, and other health problems in older adults. Additionally, benefits of hearing aid use can include improved social participation and a better quality of life.

Hearing loss is (still) one the most common work related illnesses. In addition, nonwork noise hazards are well recognized for contributing to this safety hazard as the effect carries over into work.

Impact on Occupational Hearing Safety Culture


The direct effects of noise hazard extend beyond hearing loss with problems like balance issues, tinnitus (ringing in the ears), hyperacusis (sound sensitivity). Annual audiograms, that are part of OSHA Hearing Conservation Program, may not detect early stages of hearing loss or the other associated symptoms. 


The indirect effects of hearing loss are several including heart disease, diabetes, movement difficulties, dementia.  At the occupational level, This can lead to falls, accidents, low morale, productivity loss, absenteeism. 

Unrecognized, untreated hearing loss can lead to missed warning signals, balance problems, fatigue and could be a contributing factor to OSHA's most frequently cited violations as shown below.

Per OSHA's Safety Pays estimator, it will take over $1M in sales to cover for one incidence of hearing loss - directly or indirectly.


Thus it is important for education and engagement for a personalized hearing conservation program

On-the-job noise exposure safety per 29CFR1910.95


Off-the-job noise exposure safety


Ototoxicant exposure monitoring and reduction (chemicals, drugs)

Recognition and treatment of other health conditions that worsen hearing damage 


Self-management of personal hearing conservation leading to early recognition and treatment of hearing loss (eg by OTC hearing aids) 

This will ensure Fitness for Duty, Retention, Morale, Performance and overall Quality of Life

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