June 2023: Over-the-Counter Hearing Aids — Using Regulatory Policy to Improve Public Health
The issue
On October 17 2022 the U.S. FDA created a new class of over‑the‑counter (OTC) hearing aids that adults can buy without seeing a professional, aiming to fix the long‑standing problem that most older Americans with hearing loss never receive treatment.
What do I need to know?
Hearing loss is now regarded as the largest modifiable risk factor for dementia, yet fewer than 20–30 % of adults in high‑income countries use hearing aids and uptake is below 10–15 % elsewhere. Historic rules that forced sales through licensed dispensers left five firms controlling 90 % of the global market and pushed average U.S. prices to about $4,700 per pair, making them one of the biggest purchases many seniors ever face. The new OTC category lets tech companies enter with simpler devices capped at safe sound levels, promising competition that could drop prices toward the $100‑$300 range typical of quality earbuds. OTC aids suit the 90 % of people whose loss is mild‑to‑moderate; those with more severe loss will still need prescription aids or cochlear implants.
Potential risk of untreated hearing loss
An older adult notices occasional difficulty in noisy rooms but has never tested their hearing.
Recommended Actions
Try a free smartphone or web self‑test (e.g., hearingnumber.org) and discuss results at the next check‑up.
Keep background noise low and face conversation partners to improve clarity.
Ask whether an OTC aid might help if self‑test shows mild loss.
Imminent risk of untreated hearing loss
Self‑test or screening confirms mild‑to‑moderate loss; the person struggles with TV volume or group conversation but owns no hearing device.
Recommended Actions
Compare OTC models in the $100‑$300 range; look for return policies and volume‑limiting safeguards.
Enlist a tech‑savvy friend or pharmacist to set up the device and teach basic maintenance.
Schedule follow‑up in three months to judge comfort, battery use, and speech understanding.
Confirmed disabling hearing loss
Audiogram shows ≥ 60 dB loss, speech remains unclear with OTC aids, or daily safety is at risk (missed alarms, social withdrawal).
Recommended Actions
Seek a full audiology evaluation for prescription aids or cochlear‑implant candidacy.
Ask about insurance or vocational‑rehab funding; costs for prescription devices range widely from $1,000 to > $8,000 per pair.
Combine devices with listening strategies (captioning, face‑to‑face conversation) and fall‑prevention measures.
What can I do?
Bring these three questions to your clinician: “Am I at potential, imminent, or confirmed risk? Could an OTC aid meet my needs? How will we track my hearing over time?” Keep a diary of situations where sound is unclear, note device comfort or feedback, and record battery changes. Family members can help compare models online, read privacy notices, and ensure regular volume checks so hearing technology remains affordable, effective, and safe.
