Hearing Health and Technology -- Workshop, Project No. P171200 #00074

Submission Number:
Scot Frink
Initiative Name:
Hearing Health and Technology -- Workshop, Project No. P171200
I personally see advantages and dangers of over-the-counter hearing aid options. Market penetration among persons with mild loss (<35dBHL at any given frequency) is very low (<5%) but there is probably a good reason for that, most likely relating to cost-benefit ratio. Many patients with mild loss don't perceive enough benefit to justify costs that usually begin at approximately $800 per instrument (there is a lot of misinformation that hearing aids have to cost $3,000 each, which is on the high side; there are many lower-cost, good quality options available). From what I've heard, P-CAST and the FDA have the intentions to create a new class of devices to function in a similar capacity to reading glasses for the optical industry. These may function well for patients with no more than mild losses, but moderate or worse losses are more complicated and their effects vary with each individual such that the traditional system for distributing hearing aids is significantly more appropriate. The recommendation for over-the-counter ("OTC") devices was seen as a "third option" to supplement traditional hearing aids and personal sound amplifiers ("PSAPs"), however it is my belief that there really isn't a need for a third category, as PSAPs have essentially functioned as OTCs for many years, and with little regulation. I see the current situation as an opportunity to correct this, with two simple categories of "OTC" and "prescribed", eliminating the "PSAP" designation altogether and fixing the lack of regulations on PSAPs that has been missing for years. The problem with PSAP regulation is it is based solely on how the product is marketed and not on what the product can do. PSAPs, since they have not been properly regulated, have the potential of damaging a user's hearing if not used correctly. Since they are not meant to correct hearing loss, they should not be able to produce more volume than a certain level, as extended exposure can damage the user's hearing. It's quite obvious in how they are marketed that they are intended to attract patients who are hearing impaired, but even in their case can cause damage if not limited in the amount of amplification and output they can provide. So, if the PSAP category is reclassified as "OTC", I would recommend gain (volume) and output amounts of no more than 15dB and 80dBSPL, respectively. The 15dB gain limit would be appropriate for patients with no more than a mild hearing loss, and an output limit of 80dBSPL would be appropriate for a person using the device no more than 16 hours per day (meeting the same standards utilized by OSHA for protection workers hearing from excessive noise exposure). Anything in excess of this has the potential of damaging the user's hearing if they have normal hearing or mild hearing loss. Devices with more than a 15/80 matrix should be considered prescribed systems, similar to how certain medications are prescribed because of their potential effects if not utilized correctly or for anything less than a moderate loss. In other words, stronger devices should be limited to prescription by licensed professionals trained in their proper fitting and distribution, audiologists or hearing instrument specialists. PSAPs should be rolled into the OTC category so as to reduce confusion to the consumer by too many categories and to protect them from devices that are not regulated based on what they can do. Finally, it is disconcerting for P-CAST, the FTC and the FDA to be looking solely at the cost of the device as the issue for why market penetration for the use of hearing aids is so low. In countries which have healthcare systems where hearing aids are free, market penetration isn't much higher than it is in the United States. The role of the professional in proper hearing care is underestimated, and is honestly a significant portion of the retail cost, but is necessary to provide consumers with the best quality of care.