Free Republic
Browse · Search
General/Chat
Topics · Post Article

Skip to comments.

Did You Hear That Right? Hearing Aids Without a Prescription?...Controversy over new devices that can be bought OTC heating up.
Liberty Nation ^ | October 18, 2022 - 8:59 am | By: Scott D. Cosenza, Esq.

Posted on 10/18/2022 7:45:04 AM PDT by Red Badger

You’ll likely notice a deluge of ads about hearing aids, which are available for the first time this week without a doctor’s prescription or a consultation with an audiologist. The current rule has been five years in the making after former President Donald Trump signed the Over-the-Counter Hearing Aid Act in August 2017. It’s at least a minor win for deregulation, but controversy abounds over the elimination of professional tuning of the devices.

Hearing Aids Just Amplifiers?

The Bose company, based in Massachusetts, is mainly responsible for the change in the federal government’s policy on this issue. Famous for making speakers and headphones, Bose is ready to exploit its technology and manufacturing capacity to sell these new hearing devices. Campaign cash records show Bose spent generously to support Sen. Elizabeth Warren (D-MA) and Rep. Joe Kennedy (D-MA). Was the law changed to profit the few, benefit the many, or both?

Adam Curry, former MTV VJ and current No Agenda Show podcast host, has been an outspoken critic of such direct-to-consumer sales. A longtime user of hearing aids, Curry thinks the new devices will result in a negative experience for many. In an exclusive statement to Liberty Nation, he spoke against the updated regulations and Warren’s involvement. Curry said:

“Elizabeth Warren took big campaign donations from Bose among others to introduce the OTC legislation … She is actually hurting her beloved consumers with this. They get sh—- hearing ‘amplifiers.’ That’s the real change. These Silicon Valley ‘amplifiers’ may now be marketed as ‘hearing aids.’”

Curry concluded with “Words matter.”

The legislation prompting the change was introduced in 2017 by Kennedy in the House and Warren in the Senate, passing without opposition as a rider to an FDA reauthorization act. Why would Americans need a prescription for a contraption that has a microphone and a speaker at its core? Its use is not dangerous or habit-forming.

When such a product is designed and sold to correct or cure a medical problem, it becomes a “medical device” under the law, and the FDA has vast control over it. Ask anyone who needs the most commonly used medical device, eyeglasses, which still require a prescription for purchase in the United States. The issue here concerns amplification devices for people with normal hearing acuity and processing, and hearing aids required for more profound hearing difficulty. The FDA said the rule “applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices.”

Promises Made or Bought?

President Joe Biden spurred his FDA to make a final rule on the topic as part of an executive order issued last year. Curry said the most important thing going forward is to make sure companies’ desire for recurring revenue models doesn’t impose harsh outcomes for users. “What is also important is that ALL companies, including the legit [hearing aid] manufacturers, stop tying everything to their cloud.” He said centralizing any medical device where it is “almost impossible to use … without being tethered to their infrastructure” is a horrible idea.


TOPICS:
KEYWORDS:
Navigation: use the links below to view more comments.
first previous 1-2021-4041-6061-71 next last
To: Red Badger
>a “medical device” under the law

Tongue depressors are FDA certified medical devices. Lots of things hyped and sold on TV and OTC are FDA certified medical devices and don't receive any more scrutiny than you'd expect of tongue depressors. They glom onto the public's knowing the FDA regulated the heck out of Rx drugs and expect customers to think the same standards apply to devices. They don't. For many medical devices the feds barely check to see you can't easily kill yourself with them. They just collect their fees and move on.

21 posted on 10/18/2022 8:18:15 AM PDT by JohnBovenmyer (Biden/Harris press events are called dodo ops)
[ Post Reply | Private Reply | To 1 | View Replies]

To: peggybac

“I buy my reading glasses in bulk at the dollar store. “

Did that too for years — but cataracts removed the need after the surgery.

Want mine ?


22 posted on 10/18/2022 8:19:03 AM PDT by George from New England
[ Post Reply | Private Reply | To 17 | View Replies]

To: Don Corleone
I think that efective hearing aids are more than just amplifiers. In my case, the doctor first tested my hearing and mapped out the frequencies which were below par. For me, those were in the higher range, above 3 MHz. My hearing loss was not linear from that point, but rather a complex curve up to 20 MHz. This curve was then programmed into my hearing aids to reproduce what I might hear if my hearing were normal. Without the doctor's help, the hearing aids would have amplified frequencies which were not impaired and would have seemed too loud, while at the same time not giving me amplification where I actually needed it.

The doctor scheduled several follow visits, which I found very useful. She told me that because I had adapted to my hearing loss, the corrected spectrum I was now hearing would seem too tinny and sibilant, but that I would gradually re-adapt to normal hearing. Without that advice, I would not have persisted to the point where now everthing seems good.

23 posted on 10/18/2022 8:19:13 AM PDT by PUGACHEV
[ Post Reply | Private Reply | To 5 | View Replies]

To: PUGACHEV

3 MHz — are you one of the bionic people ?


24 posted on 10/18/2022 8:20:21 AM PDT by George from New England
[ Post Reply | Private Reply | To 23 | View Replies]

To: pingman
"While genuine hearing aids are indeed expensive, you’re getting a product tailored to your specific loss, not just a boom-box in your ear."

Given the advances in miniaturization and computerization, it is quite possible to build and sell a multi-frequency device. My WORST experiences have come at the hands of "professional audiologists". My best experience has come from the hearing techs at Costco. My $1500/pair Kirkland aids work just as well as my $6000/pair Siemens (actually better, because I can tie the Kirklands to any computer via bluetooth). Bluetooth "does" require a special/separate dongle. Newer ones are coming with bluetooth built into the aid.

My biggest objection is that they are tying these aids to "rechargeability", which, IMO is a huge mistake. When my battery runs down, I want to reach in my pocket, pull out a new one, put it in, and go on about my business. I do NOT want to have to put it in a charger and wait for it to recharge.

25 posted on 10/18/2022 8:20:31 AM PDT by Wonder Warthog (Not Responding to Seagull Snark)
[ Post Reply | Private Reply | To 8 | View Replies]

To: Red Badger

I have hearing aids from the VA but rarely use them. The other evening I decided to wear them and walk out on the porch( I live on the side of a wooded mountain in a very secluded area). I could not believe what I was hearing, it sounded like something out of a jungle scene in a movie. I quickly turned the volume way down low as it was unbearable to hear all those sounds. Now I know why I barely use them.


26 posted on 10/18/2022 8:20:31 AM PDT by eastforker (All in, I'm all Trump,what you got!)
[ Post Reply | Private Reply | To 2 | View Replies]

To: Red Badger

If I bought hearing aids, I’d have fewer reasons to ignore my wife...I’ll wait until I really can’t hear! LOL!


27 posted on 10/18/2022 8:22:23 AM PDT by ExTxMarine (Diversity is necessary; diverse points of views will not be tolerated.)
[ Post Reply | Private Reply | To 1 | View Replies]

To: dljordan

“ I got mine from Vioxx. How’d you get yours?”

Decades of shooting, power tools and playing in rock bands.


28 posted on 10/18/2022 8:32:25 AM PDT by jdsteel (PA voters: it’s Oz or Fetterman. Deal with it and vote accordingly.)
[ Post Reply | Private Reply | To 6 | View Replies]

To: Wonder Warthog

Agreed. My 8-tear old Phonak ITE devices were BT, and I had to wear a dongle around my neck to make the BT connection. Apart from the appearance, it worked slick-ly. My new Phonak devices are BT direct, no dongle, but rely upon a phone “app” to function. NOT an improvement. They are inferior for use in answering phone calls. My AuD had to finagle the mics so that I could hear my own voice clearly while on the phone, and having to press the lil’ bitty program button on the aid in my ear is the only way to answer the phone while driving. The button will wear out quickly, IMO, it’s the weakest link. Sound wise, they are much better than the older version, however, it makes my wife’s voice sound like she has developed a lisp! (She wasn’t amused when I pointed it out.)


29 posted on 10/18/2022 8:32:32 AM PDT by pingman ("I ain't in no ways tarred.." of WINNING!)
[ Post Reply | Private Reply | To 25 | View Replies]

To: George from New England; Don Corleone

3K would be correct, not 3M.


30 posted on 10/18/2022 8:34:57 AM PDT by jdsteel (PA voters: it’s Oz or Fetterman. Deal with it and vote accordingly.)
[ Post Reply | Private Reply | To 24 | View Replies]

To: dljordan

US Navy and skeet and trap shooting with cotton in ears 55+ years ago before audio shooting headgear.


31 posted on 10/18/2022 8:35:19 AM PDT by Grampa Dave ( Anyone, who can make you believe in absurdities, can make you commiit atrocities!!" ~ (Voltaire)!, )
[ Post Reply | Private Reply | To 6 | View Replies]

To: dljordan

Believe it or not, I got mine from being very close to roaring lions too many times.

I got new hearing aids a couple months ago, and they are going to start working on addressing my tinnitus next week. They say there is about a 35% success rate in eliminating or greatly reducing it.


32 posted on 10/18/2022 8:35:36 AM PDT by gitmo (If your theology doesn't become your biography, what good is it?)
[ Post Reply | Private Reply | To 6 | View Replies]

To: PUGACHEV

Bkmk


33 posted on 10/18/2022 8:38:01 AM PDT by kelly4c
[ Post Reply | Private Reply | To 23 | View Replies]

To: jdsteel

Exactly

Humans close to birth may hear from 20 cycles to 20,000 cycles

Speech is in the 300 to 5,000 cycle range.

My hearing is limited to about 12,000 at age 67. 12k

If you can’t hear above 3k, understanding is poor unless you are right upon the talker.


34 posted on 10/18/2022 8:38:36 AM PDT by George from New England
[ Post Reply | Private Reply | To 30 | View Replies]

To: George from New England

I’ve got so many that there will be extras when I die!


35 posted on 10/18/2022 8:43:13 AM PDT by peggybac (My will is what I wanted. God's will is what I got.)
[ Post Reply | Private Reply | To 22 | View Replies]

To: Red Badger

Freedom works!

It takes time for markets to work and consumers to become educated.

The old way is still an option for those who prefer it.

I like to have choices, if they don’t involve murder.


36 posted on 10/18/2022 8:45:20 AM PDT by Brian Griffin
[ Post Reply | Private Reply | To 1 | View Replies]

To: Wonder Warthog

My Sony R-1 camera has in camera recharging.

My Canon cameras have separate rechargers.


37 posted on 10/18/2022 8:48:53 AM PDT by Brian Griffin
[ Post Reply | Private Reply | To 25 | View Replies]

To: pingman

The consumer should have the choice. Earbuds are ubiquitous these days and the technology can be easily adapted for cheap over the counter hearing aids. To require a prescription is just to artificially inflate the cost. The consumer can always go with the prescription models if they are unhappy with the OTC models.


38 posted on 10/18/2022 8:54:05 AM PDT by circlecity
[ Post Reply | Private Reply | To 8 | View Replies]

To: George from New England

Hate to give business to slave labor/robots in China, but Zenni optical is great.

If you have your prescription and interpupiliary distance, their glasses are very inexpensive; For a simple reading prescription mine were about the same as the Cheaters. And was finally able to afford prescription safety glasses.


39 posted on 10/18/2022 9:15:26 AM PDT by Republican in occupied CA (I will not give up on my native State! Here I was born, here I fight and die!!)
[ Post Reply | Private Reply | To 20 | View Replies]

To: gitmo
going to start working on addressing my tinnitus

High quality ginko brought my tinnitus under control.

40 posted on 10/18/2022 9:19:50 AM PDT by aimhigh (THIS is His commandment . . . . 1 John 3:23)
[ Post Reply | Private Reply | To 32 | View Replies]


Navigation: use the links below to view more comments.
first previous 1-2021-4041-6061-71 next last

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
General/Chat
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson