Hearing Health and Technology -- Workshop, Project No. P171200 #00091

Submission Number:
00091
Commenter:
Timothy Chapman
State:
Arizona
Initiative Name:
Hearing Health and Technology -- Workshop, Project No. P171200
I hope we are ALL on board with fighting this thing. The implications are far more reaching than I'm hearing from many industry leaders who should be in the forefront of this battle. There are solid reasons to oppose the OTC regulation, one of which is its utter destruction of the consumer protections and safety net This is from one of my recent communications with a state I'd like to add a couple of caveats--as I know that when we mention the kinds of conditions that are found only through the safety net of the current FDA regulation that the public is not aware of life-threatening conditions, such as glomus tumors, external ear cholesteatomas, septic keratosis obturans, acoustic neuromas, cochlear stroke, episodic Meniere's, vestibular Schwannomas, psuedomonas, and sudden hearing loss syndromes. Earwax is the least of any concern and is about the only one that is detectable by the patient. (Most of what is considered impacted cerumen nowadays is instead a septic keratosis obturans). Every study on OTC to-date totally misses these points and most everyone seems happy to slide over the presence of these conditions and therefore, we see that the OTC bill will immediately do away with the FDA Red Flag and Medical Clearance requirement. That this is on the back shelf of discussion is the most alarming feature of virtually position paper today. Yours makes brief mention of it, which puts you heads above the rest. Let me give you a few of important references that might bolster your position paper even more: -Chartrand, MS (2017). Septic Keratosis Obturans: A stealth public health threat. Otolarnyngology, found at www.omicsonline.org/open-access/.... -Chartrand, MS (2003). Video Otoscopy and the FDA Red Flags: Observation & Referral. Found at www.ihsinfo.org/IhsV2/Hearing_Professional/2003/.... -Chartrand, MS (1999). Hearing Instrument Counseling, second edition. Livonia, MI: International Institute for Hearing Instruments Studies. (I recommend the above tools as part of anyone's knowledge on the topics surrounding the OTC and loss of the FDA regulations--this information is so vital to have the depth and power of arguments that will protect this for the consumer). The over-the-counter hearing aids can be sold to an unsuspecting public by unlicensed individuals. To be sure, the mild to moderate category (interpreted by virtually everyone even the studies you cited) to mean mild and moderate loss comprises, in fact, over 85% of the hearing impaired population. That leaves only 15% of the hearing impaired in the moderately-severe, severe, and profound losses. Most people end up waiting until they are moderately severe before doing anything about their loss, and it might surprise you that our several studies on the topic find that MOST of those in the moderately severe, severe, and profound categories still do not seek out hearing aids without help from someone (I track those categories, by the way). Self-assessment studies are notoriously unreliable. That is why third party psychology is so prominent in this field. This is an article written by Max Chartrand that articulates exactly what most hearing professionals are concerned about. Please understand that the only ones that will benefit from an over the counter hearing aid is the electronics manufacturers that are lobbying so heavily to push this through. This is not in the best interest of the hearing impaired community. Thanks. Tim Chapman