FDA Approves an OTC Hearing Aid

Katherine Bouton Bose, Healthy Hearing, OTC Hearing Aids

For the past year or so since the Over-the-Counter Hearing Aid Act of 2017 was passed, I and other hearing-loss advocates have patiently explained time and again that right now there are no OTC hearing aids. That’s because the FDA approval process includes a three-year comment period before it publishes its final regulations. And until that time, only hearing “devices” can be sold over the counter.

Or at least that was what we thought. Last Friday (October 5), the FDA took almost everyone by surprise when it announced that it had approved a Bose hearing aid that consumers will fit and program themselves.

The Bose Hearing Aid, the FDA announcement said, is intended for adults over 18 with perceived mild to moderate hearing loss. “This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider,” the announcement said. The wireless device processes sound through an earphone in the ear canal, and the user programs the aid on a smart phone.

The FDA does require compliance with sales regulations, “including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser.”  I’m not sure how many states have that regulation. Would welcome enlightenment.

The Bose Hearing Aid is not yet available, nor has the price been set, but Bose has landed a huge coup. As Abram Bailey at Hearing Tracker noted, “Bose has effectively been granted a very unique position by the FDA.”

The Bose Hearing Aid will be a new product, according to Sandy Weiss at Bose, rather than an adaptation of Bose’s Hearphone, which is a PSAP. As for when they will be available, Ms Weiss said in an email, there is as yet no new product announcement or distribution plan. She added that while details about future pricing are confidential, Bose does “expect to offer more affordable solutions than traditional hearing aid solutions currently on the market.”

So what made the FDA decide to approve this particular hearing aid? After reviewing data from clinical studies of 125 patients the FDA found the results persuasive enough that it approved the Bose Hearing Aid under its De Novo premarket review pathway. The De Novo pathway allows expedited approval of “low- to moderate-risk devices that are novel and for which there is no prior legally marketed device”. (Click here to see a list of other devices approved under the De Novo pathway so far in 2018.) Not only were the results of self-fitting comparable with those of a hearing professional, the FDA noted, but participants in the trial generally preferred their own settings over those selected by a hearing aid professional.

The announcement was made after the close of the European stock markets on Friday but by 10 AM Eastern time on Monday, the shares of the Danish companies GN Store Nord and William Demant Holding had each fallen by 13 percent, with Switzerland’s Sonova dropping 10 percent The American markets saw a similar drop. Obviously Bose, a privately held company, is seen as a threat to conventional hearing aid sales.

 

 

 

Want to Help People with Hearing Loss?

Katherine Bouton Healthy Hearing

Dear Readers,

This is an unabashed pitch for contributions to the Hearing Loss Association of America, which has helped me and millions of others to live better with hearing loss. Please help sustain HLAA’s advocacy and education by supporting me in this year’s Walk4Hearing, our annual fund-raising and awareness event, which takes place September 23.fb_nyc_chapter FB profile

Click on this link now before you forget. Fill in my name in the space provided on the right (you may need to click on “participant”). Join our team, or donate to support our work.

HLAA has worked tirelessly to change the way hearing aids are sold, resulting in the passage of the historic Over the Counter Hearing Aid Act of 2017, which will benefit many millions of people who cannot now afford hearing aids.  The next step is to get health-insurance to cover the cost.  Currently, Medicare does not cover hearing aids, a proven health benefit to the 30 million older Americans who need them.

Hearing loss is no minor nuisance associated with growing older. It affects people of all ages and has been linked to depression, lost employment, cognitive decline and a greater risk of falls in the elderly. It is usually totally treatable.

         Please help sustain and advance our work by donating to our annual event. Click on this link to support me personally (by clicking on my name) or our team. 

Your contribution will also help support the New York City chapter of HLAA, of which I am the president. We provide support and education to New Yorkers with hearing loss, and we have lobbied successfully for hearing access in both public and private venues.

Mayor 2017 bill
March 21, 2017, New York becomes the nation’s first major municipality to require hearing loops in places of public assembly.

Thanks to HLAA advocacy, the city has installed high-quality hearing assistive devices—hearing loops – in City Hall, and in 2017 passed a law requiring all new and renovated city buildings to include at least one meeting space with a hearing loop. Live captioning and ASL interpreters are also available on request.

If you love movies, you have probably encountered the captioning devices now available at all chain theaters and many independents. If you are a theater-goer, check out the Gala-Pro app that provides captioning on your smart phone or tablet for all Broadway and many off-Broadway theaters, many of which also have hearing loops.  If you like restaurants but hate the noise, two new smart-phone apps, iHearU and Soundprint, allow you to check in advance the noise levels of a particular restaurant, and to make your own rating. Yelp for noise!

All of these were achieved through HLAA advocacy.

Thanks for your past contributions. Even small donations make a big difference.

 

Hearing Aid Facts and Figures

Katherine Bouton #HLAA., FDA and hearing aids, Hearing Aids, OTC Hearing Aids

Almost a year after the passage of the Over-the-Counter Hearing Aid Act of 2017,  I was curious to know if the bill and the attendant publicity had affected the hearing aid marketplace. So I asked an expert: Abram Bailey of Hearing Tracker.save-money-image

OTC hearing aids won’t be on the market for months, if not years. But the one-year anniversary seemed like a good time to try to establish some kind of benchmark in terms of sales, prices, location where purchased, brands, cost and other issues that may begin to shift after OTC hearing aids become available.

The bipartisan OTC bill, sponsored in the Senate by Republican Chuck Grassley and Democrat Elizabeth Warren, was signed into law by President Trump in August 2017. The FDA, which regulates hearing aids, has three years from the time the bill was signed for comments and questions. The final regulations will reflect the views not only of consumer advocates but also of audiologists and other medical professionals as well as hearing aid companies and dispensers. Until that comment period is over, there will be no OTC hearing aids.

Abram Bailey constructed a survey that was filled out by over 2000 consumers. (Here is a link to the survey) The respondents were a self-selected group, already aware of their hearing loss and many already wearing hearing aids. The survey was sent to Hearing Tracker followers, HLAA members, and people who follow my blog.

Part 1 of the survey was published last week. Parts 2 and 3, focusing on hearing-aid preference and recommendations, insurance coverage, and purchase of accessories (assistive listening devices, for instance), will be published in the coming weeks.

The survey first established the demographics of the respondents: 54.7 were female and 44.2 male. More than three-quarters were over the age of 55, with pretax income that reflects that of the population at large. More than half were retired. Their self-reported levels of hearing loss ranged from mild to profound, with 18.2 percent reporting that their hearing loss was profound, and 31.4 percent reporting severe hearing loss. As would be expected from the respondents surveyed, many were experienced hearing aid users, over half with 10-plus years of use. This is a very different sample from those who are just now becoming aware of their loss and buying hearing aids, but the trends are interesting.

Almost all (84 percent) bought a pair of hearing aids, as opposed to a single aid. More than half bought what they understood to be top-end hearing aids and more than a third bought mid-range hearing aids. The average price paid was $2560 for a single aid, or $2,336 per aid when purchased as a pair. This is more or less in line with the reports from the President’s Commission on Hearing and Technology (October 2015), which recommended a “basic” hearing aid, and the National Academies of Sciences, Engineering and Medicine (June 2016), which found an average cost of approximately $4700 for a pair of hearing aids.

The top brand purchased by survey respondents was Phonak, with Oticon and ReSound second and third. Eleven other brands were purchased by at least 10 respondents. Not surprisingly, the share of the US market reflected sales figures, with Sonova (Phonak) accounting for 30 percent. William Demant (Oticon) and GN Resound third. All three also own other brands. (The market share statistics date from 2015, and may have changed.)

Did cost affect market share? Starkey (# 4 in market share at 16 percent) had the highest average price paid ($2,674), with Widex (with 3 percent of market share) being the second most expensive ($2,672). The least expensive were Kirkland Signature (Costco’s house brand) at $963.

I was interested to see that the vast majority were fitted by and bought through audiologists (75.18 percent) or hearing-instrument specialists (20.46 percent) Audiology training is far more rigorous than that of hearing instrument specialists. Hearing aids sold by audiologists (1056 responses) cost on average $2,499 per device, those sold by hearing instrument specialists (337 responses) $1944 averaged per device.

The data also revealed, however, that hearing instrument specialists and audiologists seemed to charge the same amount when in similar settings (a local office, for instance). The disparity may reflect the fact that at Costco hearing professionals are mostly hearing-instrument specialists (40 percent) with only 4 percent audiologists. Those who bought at Costco, the survey found, were more than twice as likely to have been fitted by a hearing aid specialist as by an audiologist. Costco’s current estimated market share is 11 percent of all US hearing aid sales.

Costco sells, in addition to its own brand, Phonak and Resound, at vastly reduced prices. How is this? Abram Bailey speculated that it may be due in part to the fact that the aids sold are not the brand’s latest model (usually one generation behind flagship stores) Costco also can purchase in volume, and has very little overhead for its hearing aid sales.

Most surprising to me was the response to a question about the length of time it took for respondents to buy hearing aids once they had learned about their hearing loss. It is commonly said that most people wait 7 to 10 years before buying hearing aids. Over half the survey  respondents reported buying their first hearing aids within two years of learning they had a loss. As Bailey noted, this discrepancy may be the result of sampling bias (the respondents were all already hearing-aid users) or erroneous self-reporting (a respondent might like to think she had bought hearing aids within two years when in fact it had taken her 4-5 to make that decision.)

As the survey says, Stay tuned for more.

 

 

Do Your Hearing Aids Sweat?

Katherine Bouton #hearingaids, #HLAA.

outdoor-thermometerhygrometer-picture-id153970895

It’s hot. And humid.

Perfect weather for ruining your hearing aids.

Moisture. Whether it’s humidity or sweat, getting caught in a downpour, or diving into the pool, moisture is terrible for your hearing aids. It’s damaging to the delicate inner workings (the microphone, flexible circuit board, disposable battery, receiver and antenna). And it can clog the tubing that connects your behind-the-ear processor to the in-the-ear component.

Wax: Hot weather seems to increase wax buildup, which can block your hearing and makes your hearing aid dirty. If you have a custom mold, waxy buildup may make the in-the-ear mold uncomfortable. If your hearing aid has wax guards, make sure you replace them regularly. If it doesn’t, a small brush and pick to clean wax out of the tubing and ear mold is helpful. Don’t forget to clean the battery compartment.

Full immersion? Accidentally dunked your hearing aids?  Don’t panic. Take the hearing aid out and remove the battery (discard it). Shake the hearing aid to remove any excess moisture. If the water is salt water or dirty, rinse the component with fresh water. Dry it off and then leave it on dry newspaper overnight. You can also use a hair dryer but only on a cool setting. Audicus suggests putting the aid into a jar of uncooked rice. Never expose the hearing aid to heat, and if you’re thinking maybe the microwave would be faster, don’t do it!

Many people routinely put their hearing aids in a hearing aid dehumidifier overnight. This would also be a good place for the wet hearing aids as well. Harris Communications offers a variety of these, as does Amazon.com and other retailers..

Do hearing aids sweat? No, it just feels like it.

For more about living with hearing loss, see my books at Amazon.com.

 

Where Hearing Loss is the Norm

Katherine Bouton #hearingaids, #HLAA., Healthy Hearing, hearing aid costs

There’s one event a year where my hearing loss is not afb_nyc_chapter FB profile factor in my ability to communicate.

That’s the Hearing Loss Association of America’s annual Convention.

This year’s convention was held in Minneapolis June 21st to June 24th. I don’t know how many attended but virtually everyone was deaf or hard of hearing – or accompanying someone deaf or hard of hearing. A few audiologists also attended – it’s great to see their interest in what people with hearing loss want and need.

Convention is a mix of lectures, workshops, parties, seeing old friends and making new ones.

GIRLS OF MINNEAPOLIS
At Convention, where hearing loss is the norm.

The larger events – the keynote address, the research forum, the awards brunch – offer three different forms of hearing accommodations: a hearing loop, CART captions, and ASL interpreters. The smaller workshop gatherings provide CART, some offer looping as well, and an ASL interpreter was available on request.  My hearing loss is severe enough that I need CART as well as the loop. The Deaf may use CART to elaborate on what they hear through the ASL interpretation. It’s actually thrilling to be in a place that offers so many different ways to hear

This year’s keynote speaker was Gary Shapiro, president and CEO of the Consumer Technology Association. Consumer electronics are playing an ever larger role in correcting hearing loss. Shapiro’s talk was a guide to this exciting new field of hearing instruments.

The three-hour Friday morning research symposium consisted of a panel of four experts discussing listening in noise. They explained why it is so difficult for hearing aids and cochlear implants to correct for background noise, and technological innovations that  may solve this problem.

As always, there was a large exhibit hall where you could try out new devices, find out how to get a hearing dog, how to add an app to your smartphone to make it easier to understand on a cell phone. My cochlear implant manufacturer, Advanced Bionics, even made a minor adjustment to my cochlear implant at the convention, adding a small magnet to my headpiece, which had been slipping.

The themed Get Acquainted Party is always popular with newcomers and old hands alike. This year’s theme was the 70’s, complete with Go-Go dancers and hilarious costumes. On Saturday evening, Mandy Harvey, a deaf singer-songwriter who was also an America’s Got Talent winner, gave a concert for a few hundred people, some of whom could not resist getting up to dance.

Saturday night, a group went to the famed Guthrie Center for a performance of “West Side Story.”

Workshops on four educational tracks occupied the daytime hours. These tracks included Advocacy, Hearing Assistive Technology, Living with Hearing Loss, and Hearing Loss in Health Care settings. The last category is a new one for HLAA, and it addressed how people with hearing loss can make sure an encounter with the health-care system includes clear communication from health-care professional to patient, and vice versa.

In between formal events, friends met for meals, or a walk in beautiful Minneapolis, or took a trip to the Walker Art Museum and the adjacent outdoor sculpture park. Big name tags with large print make it easy to strike up conversations with new people or those you may have met at other conventions. As a person with hearing loss, I find name tags one of the most gratifying aspects of convention. I am bad at hearing names and bad at remembering them, which makes it hard to initiate a conversation with someone new, and sometimes even with people I know quite well, when the mind balks at remembering. Name tags do the work for me.

Almost everyone at Convention is hard of hearing, and accommodations are provided as a matter of course.  It’s fun – and also something of a relief – to be the norm for a change. Next year’s Convention is in Rochester, N.Y., home to what may be HLAA’s largest chapter as well as the Rochester Institute of Technology and the National Technical Institute for the Deaf. If any city in America can be said to specialize in hearing loss, Rochester is it.

 

One Potential Way to Cure Hearing Loss

Katherine Bouton Hair Cell Regeneration, Hearing Restoration, Heroes With Hearing Loss, Research on Hearing Loss

At the end of May (May 30), a few days after Americans honored Veterans on Memorial Day, a New England biotech company announced that it had received a grant from the Department of Defense to research a therapeutic opportunity that may help reverse hearing loss.

Cochlear hair cells_Credit- W. McLean
Cochlear Hair Cells. Credit:W. McLean

A 2015 study of almost 50,000 soldiers showed that peak noise levels in combat can reach 180 dB. Combat veterans have a 63% increased risk for hearing loss. Two and a half million veterans have service-connected hearing disabilities.

Clearly there is a need for treatment.

Frequency Therapeutics based in Woburn, Mass., and Farmington, Ct., announced that it had received a $2 million grant from the Department of Defense to investigate the restoration of hearing after noise-related damage as a result of military service-related injuries.

Frequency’s Progenitor Cell Activation, or PCA Regeneration, technique, uses a combination of small-molecule drugs to stimulate inner ear progenitor cells to multiply and create new hair cells. Hair cell regeneration happens spontaneously in fish and birds, but not in mammals.

Humans are born with only 15,000 hair cells in each ear and do not develop any more after birth. Damage to these hair cells over time results in a loss of hearing. Figuring out how to make regeneration happen in mammals would be a major step towards finding a cure for hearing loss, and this goal is being pursued by others in addition to Frequency.

In December, Frequency announced the completion of the first in-human safety and tolerance study of its proprietary drug combination, FX-322. (You can read more about it here.) The drug is injected into the inner ear using a standard intratympanic injection, with the patient awake.  The Phase 1 trial was conducted at Victoria Eye and Ear Hospital in Melbourne, Australia, on 9 adults with severe to profound sensorineural hearing loss who were scheduled for cochlear implant surgery 24 hours after receiving the injection.

In the press release announcing the DOD grant, Frequency noted that the PCA Regeneration platform targets the root cause of disease without removing stem cells from the body. This avoids issues that can develop with traditional stem cell or gene therapy, which can affect cells other than those targeted. Frequency’s FX-322 awakens the dormant progenitor cells already in the ear, initiating cell division and differentiation to repair the damaged hair cells.

Frequency hopes this technique can be used elsewhere in the body as well, to restore healthy tissue, and it has a number of other programs in development including preclinical research in muscle regeneration and type 1 diabetes. Frequency plans to initiate a Phase 2 trial for hearing regeneration in the U.S. later this year.

This grant applies only to military personnel with service-related hearing loss, although of course if the technique is found to work it would be available to others with sensorineural hearing loss. More than 48 million Americans of all ages have some degree of hearing loss.

**

This study is one of many efforts to find a biological cure for hearing loss. I will be writing about others in the coming months. If you are a researcher with relevant information please email me at katherinebouton@gmail.com

 

The Noise of War

Katherine Bouton Healthy Hearing, Heroes With Hearing Loss, Veterans with hearing loss

This Memorial Day, as we honor veterans with parades and flags and, yes, barbecues, we should remind ourselves of the toll that war takes on hearing.images

Two and a half million veterans have service-connected hearing disabilities. Tinnitus is the number-one claim for all service related disability, with more than 1.5 million veterans receiving disability benefits for it. Another million receive benefits for service-related hearing loss.

Master Sgt., Donald Doherty, a retired Marine and Vietnam veteran who is now the Chair of the Board of Trustees of the Hearing Loss Association of America, lost his hearing as a result of gunfire and artillery noise during his 1965-66 tour in Vietnam. He has worn hearing aids since June 1970. He recently retired from the Department of Veterans Affairs after 25 years of service.

Doherty is a member of “Heroes with Hearing Loss,” supported by HamiltonCapTel. Heroes with Hearing Loss is group of veterans who hold interactive workshops to help veterans and their families come to terms with hearing loss and find solutions. You can follow them on Twitter at @HWHLVeterans.

Hearing loss is even more an invisible disability in the military than it is elsewhere. Among veterans it is often overshadowed by other injuries. But as Heroes with Hearing Loss notes, hearing loss and other injuries are  “intertwined both physically and emotionally — as a trigger, a constant reminder or an everyday frustration. It is a very unique and personal challenge for many veterans.” The website has a useful list of resources and web addresses. 

For the past several years the group has held a packed workshop at HLAA’s annual convention, which will be held this year June 21-24 in Minneapolis. I wrote about their 2014 presentation in “An Invisible War Wound,” published on November 11th, 2014, Veterans’ Day.

“Marines — and anyone in the armed forces — have been instilled with a sense of pride, the need to act independently, to do it yourself. It’s a sign of weakness if you reach out for help,” Doherty said at that event. Eventually, you realize it’s affecting “not only yourself but everyone around you.” Heroes with Hearing Loss helps veterans accept help.

Captain Mark A. Brogan, Ret., was one of the speakers that year. He was injured in a suicide bomb attack while on active duty in Iraq in 2006, sustaining a severe penetrating head injury, multiple shrapnel wounds, and a nearly severed right arm. He spent months in a coma at Walter Reed Medical Center. It was not until his traumatic injuries had been treated, he said, that he began to be aware of his hearing loss and its permanency.  He also began to realize how hearing loss and TBI were entwined.  The part of the brain that controls speech perception was injured in the blast, he said, and that damage combined with physical injury to the ear to make speech difficult to understand. He knew he needed help, but like many in the military asking for help was difficult.

HLAA was founded in 1979 by Rocky Stone, who also suffered service-related hearing loss. HLAA continues to honor and offer resources for veterans, on both the national and chapter level. Mark Brogan joined the Knoxville, Tenn., chapter: “It’s just good to get with  others who have the same type of disability,” he says.

To see some of the ways HLAA is involved with veterans nationally, go to HLAA’s website, or just click through directly to “Veterans.”

For more information about living with hearing loss, see Katherine Bouton, Amazon.com.