Over-The-Counter Hearing Aids: Are They Safe and Effective?

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.