In a highly controlled comparison study, several over-the-counter hearing assistance devices performed almost as well as a conventional hearing aid that cost thousands of dollars more.
Congress is currently considering rare, bipartisan legislation that would allow these devices to be marketed as direct-to-consumer products subject to FDA regulation. At present, hearing aids can only be purchased through a licensed hearing specialist.
Hearing aids for both ears typically cost around $4,500, while PSAPs cost several hundred dollars or less.
The Over-the-Counter Hearing Aid Act of 2017 is being sponsored in the Senate by Elizabeth Warren (D-Mass.) and Charles Grassley (R-Iowa) and in the House by Joseph Kennedy (D-Mass.) and Marsha Blackburn (R-Tenn.).
Reed told MedPage Today that the study findings lend support to the creation of the new regulatory classification for hearing aids.
Among the main findings:
- The hearing aid and four of the PSAPs improved speech understanding, compared to the unaided condition.
- The mean unaided accuracy was 76.5% and the hearing aid improved speech understanding accuracy to 88.4% (absolute improvement = 11.9%, 95% CI 9.8-14.0).
- Three of the PSAPs showed improvements that were within five percentage points of the hearing aid (Sound World Solutions CS50+ = 11.0, 95% CI 8.8-13.1; Soundhawk = 10.2, 95% CI 8.0-12.3); Etymotic BEAN = 7.7, 95% CI 5.5-8.9).
- Speech understanding was poorer with one device than in unaided testing (accuracy 65.3%, -11.2% difference, 95% CI -15.2 to -7.31).
Reed noted that the poor performance of the device that was not chosen for its favorable electroacoustic properties highlights the need for regulation of the products and greater transparency to consumers.