Over-the-Counter Hearing Aids Challenge the Core Values of Traditional Audiology.
Katherine N Menon, Michelle Hoon-Starr, Katie Shilton and 1 others
PMID 38329402WHAT IT FOUND
OTC hearing aid regulations prioritize ease of use, accuracy, and safety, whereas traditional audiology prioritizes patient benefit.
This shift means OTC devices may not be evaluated on the same clinical outcomes audiologists use, potentially leaving severe loss and children unserved.
Key findings
01OTC regulatory documents ranked ease of use, accuracy, and safety as their top three values, contrasting with critique documents that prioritized access, autonomy, and cost.
02Traditional audiology ranked subjective and objective patient benefit highly, but these values were deprioritized or absent in OTC regulatory documents.
03The OTC model targets adults with mild-to-moderate hearing difficulty and does not benefit those with severe loss or children who cannot self-fit devices.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
The study defines value priority by the number of words coded to a value, assuming more text equals higher importance. The analysis is limited to specific foundational documents and may not reflect current or future implementation practices. Ranking values is inherently difficult, and different methodologies (like surveys) might produce different results. The FDA document reflects regulatory constraints rather than pure clinical values, which may skew its ranking of technical specifications like accuracy.
Declared interests
Funding was provided by training Grant DC-00046 from the National Institute of Deafness and Communicative Disorders and a seed grant from the University of Maryland Brain and Behavior Initiative.
The easy way to misread this
Do not assume that OTC hearing aids are clinically equivalent to professionally fitted devices because they share the same market category. The regulations prioritize device safety and ease of use over patient-reported benefit or objective speech perception outcomes, meaning efficacy is not measured the same way.