Last week the FDA finally released its proposed regulations about over-the-counter (OTC) hearing aids. The OTC devices are intended to help adults who experience mild-to-moderate hearing loss and who would prefer a less expensive, more accessible way to hear better than with the traditional method of repeat visits to hearing specialists for testing and fitting.
The guidelines, which are open for public comment for the next 3 months, will allow more companies like ours to reach adults whose hearing is challenged in specific situations (e.g., understanding speech in noisy places, while watching TV, during cell phone calls, etc.). It will reduce the cost substantially and enable people to take charge of their own hearing by deciding where to purchase hearing solutions, and how and when to personalize them.
The safety and effectiveness guidelines detailed in the proposal have already been met by the entire Behear line.
Bottom line: this news is a concrete step in removing the barriers to hearing health for the millions of people worldwide who have untreated hearing loss. Questions?