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Related Experiment Video

Updated: May 3, 2026

Neuro-rehabilitation Approach for Sudden Sensorineural Hearing Loss
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Over-The-Counter Hearing Aids: Are They Safe and Effective?

Rema Shah1, Sarah G Wilkins1, Neelima Panth1,2

  • 1Yale University School of Medicine, New Haven, Connecticut, USA.

Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery
|May 21, 2024
PubMed
Summary

Over-the-counter (OTC) hearing aids are comparable in safety to prescription devices but show slightly lower efficacy. Further research is needed to optimize OTC hearing aid performance for diverse hearing loss types.

Keywords:
efficacyhearing aidshearing‐losssafety

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Area of Science:

  • Audiology
  • Regulatory Science
  • Biomedical Engineering

Background:

  • The US FDA established a new category for over-the-counter (OTC) hearing aids in 2022.
  • These devices are intended for individuals with mild to moderate hearing loss.

Purpose of the Study:

  • To compare the safety and efficacy of OTC hearing aids against prescription hearing aids.
  • To evaluate device performance across different hearing loss configurations.

Main Methods:

  • A comparative-effectiveness model was employed.
  • Safety and efficacy were assessed using AudioScan Verifit 2 Testbox software.
  • Three hearing loss patterns (downsloping, sharp downsloping, reverse sloping) were analyzed at three volume inputs.

Main Results:

  • Prescription hearing aids demonstrated a better safety profile, particularly at 8000 Hz for downsloping hearing loss patterns.
  • Prescription devices showed a statistically significant advantage at three test points.
  • OTC hearing aids generally exhibited a larger discrepancy between tested and target output levels.

Conclusions:

  • OTC and prescription hearing aids are found to be comparably safe.
  • OTC hearing aids were observed to be slightly less efficacious than prescription devices.
  • Further investigation into OTC hearing aid efficacy is recommended to ensure adequate benefit for various hearing loss types.