In October 2022 the US Food and Drug Administration created an over-the-counter category for hearing aids, allowing them to be sold from stores or online without prescription or seeing an audiologist. What impact has this had there and how may this influence Australia?
While Australia’s Therapeutic Goods Administration (TGA) says it has no current plans to change how hearing devices are regulated in Australia, it says that over-the-counter (OTC) hearing aids can be supplied here subject to its approval. Several companies are already doing so.
In America, the FDA says it created the category to overcome barriers such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price) as well as to increase access to hearing assistance allowing consumers an additional option for addressing their hearing health. Its justification was that nearly 30 million adults living in the US have hearing loss but only about one-fifth who could benefit seek a hearing aid intervention.
The FDA classified OTC hearing aids as medical devices and electronic devices for people aged 18 and over with perceived mild to moderate hearing loss. Buyers do not need a prescription, fitting by an audiologist or a medical examination and sellers do not need to be licensed. The devices may be bought in-person, by mail or online without involvement of a licensed hearing healthcare professional.
There are two categories; those with basic features such as volume control and a few predetermined settings; and self-fitting versions which allow consumers to customise their fitting and program device settings to suit their hearing needs through technology including software. This category must be reviewed by the FDA before sale via premarket notification.
People do not need to provide age verification or measurements of hearing loss to buy OTC hearing aids.
“We intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health,” the FDA says in a statement on its website.
The FDA regulations require certain information on the outside of the box for OTC hearing aids. These include warnings against using them if under 18, advice on when to seek health care services, red flag conditions, and symptoms suggesting perceived mild to moderate hearing loss.
Overall positive move
Leading American audiologist Dr Steve Taddei says the move has had good and bad effects. While it has increased overall hearing health awareness, it has also confused consumers. His company found the audio performance of OTCs varies and while some can offer similar benefits to prescription hearing aids for mild-to-moderate hearing loss, others can potentially worsen speech clarity. But overall, he says it is a step in the right direction with many positive changes to consumers and the field.
Dr Taddei is co-founder and lab director of HearAdvisor, an independent test laboratory, where he works as an audiologist. He is also an audio engineer and teaches audio production and hearing sciences at several universities.
“Our team of two audiologists and one hearing scientist came together based on barriers we observed with the roll-out of over-the-counter hearing aids,” he told Hearing Practitioner Australia (HPA). “We have tested more than 70 prescription and over-the-counter hearing aids and advanced earbuds since we launched in 2022. Our goal is to offer consumers objective and unbiased information regarding hearing aid audio performance.
“Since the 2022 over-the-counter ruling, the hearing aid market has seen an influx of new companies and products, along with heightened media coverage and increased overall hearing health awareness.
“While these developments have been beneficial, confusion has also grown as consumers struggle to understand this new category and determine which devices, if any, are suitable for their hearing needs.
“Many people face challenges finding unbiased guidance in their search for better hearing. Among these challenges are affiliate-driven websites and companies using similar marketing claims for their products, which can be particularly confusing given that prices range from under $100 to several thousand dollars per product.”
Dr Taddei says the HearingTracker industry map highlights how confusing the market has become based on the number of companies alone.
“One thing we are finding is that the audio performance of OTC products varies almost as much as their prices,” he told HPA. “To date we have objectively tested more than 70 hearing products in our lab, and while some OTC hearing aids can offer similar benefits to traditional prescription devices for those with mild-to-moderate hearing loss, others can potentially worsen speech clarity.
“Not surprisingly, the worst performers tend to fall in the sub-$500 category,” he adds. ” Products priced between $500 and $1000 show a wide range of performance, whereas those above $1000 generally offer the best audio quality.”
Minimal impact on prescription sales
Dr Taddei says, looking at the industry as a whole, OTC sales appear minimal and have had little impact on the prescription market.
“According to the (American) Hearing Industries Association (HIA), OTC sales accounted for only 1% of the overall 9% increase in hearing aid sales in the first quarter of 2023 compared to the previous year,” he says.
This is equivalent to at least 13,000 OTC hearing aid sales from January to March 2023.
“The 2022 ruling was a step in the right direction and has brought many positive changes to both consumers and the field,” Dr Taddei adds.
“It is important to note that OTC hearing aids are still in their infancy, so while barriers exist, we expect to see long-term benefits in terms of quality technology and consumer hearing outcomes.
“In the meantime, we should strive for better consumer protection and higher quality standards across all hearing products.”
Meanwhile, the first market survey in the OTC space to determine the public perception is being planned for late 2024 in America, according to Ms Bridget Dobyan.
Dobyan is executive director of the Hearing Industries Association (HIA) and was speaking to American thought leader in hearables and hearing health, Mr Andrew Bellavia on This Week in Hearing podcast on 6 June 2024.
The HIA is a forum for hearing aid manufacturers, suppliers, distributors, and hearing health professionals in the US and the only association in the US to represent hearing aid technology.
Its members are responsible for most of the more than four million hearing aids that are bought in the US annually. Its MarkeTrak survey collects data on hearing loss and hearing aid usage.
“Our next MarkeTrak will be fielding later this year with results expected in 2025,” Dobyan told This Week in Hearing.
“MarkeTrack 2025 will be the first survey in the OTC space and we’re looking forward to this potential to obtain additional insight into OTC and consumer behaviours and perceptions, and if they have shifted in the last couple of years in this new reality.”
Its 2022 survey sampled 15,000 households including 3,218 people with hearing difficulty.
HIA warns that online descriptions of OTC hearing devices may not include all information required to be on packaging and suggests searching for reviews of the manufacturing company to ensure others have had a positive experience with the device and customer service.
Australian situation
A Department of Health and Aged Care spokesman told HPA on 22 July 2024 that the TGA has no plans to change how hearing devices are regulated in Australia and that subject to its approval, hearing aids can already be supplied OTC.
“In Australia, hearing aids are considered medical devices and require TGA approval before being supplied – regardless of whether they are sold over the counter (OTC) or prescribed by a health practitioner,” the spokesman said. “Subject to the TGA’s approval, hearing aids can already be supplied OTC in Australia. The TGA has no plans to change how hearing devices are regulated in Australia.”
OTC hearing aids are being sold including by audiologists, audiology practices and online.
Australian audiologist Ms Suzanne Porter and audiometrist Mr Don Hudson founded PocketAid, a direct-to-consumer hearing aid provider in 2024 after they saw a gap in the market for a “broad prescription and ready-to-use hearing aid”. They originally developed the hearing aid for audiologists to lend patients awaiting their prescription devices but said many customers reported that these outperformed the prescription hearing aids that had cost them thousands of dollars.
Porter and Hudson used hearing test results of more than 1,000 people with hearing loss to design PocketAid backed by research. “Our hearing aids are powered bys technology which we developed in-house; a broadly prescribable and automatic way of enhancing sounds, catering to everyday needs of the majority of those with hearing loss,” Hudson says.
“We’re aiming to improve accessibility for the vast majority of people who suffer from hearing loss and reduce the stigma associated with hearing aids. The products we’ve designed mean Australians can address their hearing needs and difficulties quickly with ready-to-use hearing aids straight from the box without the need for in-clinic appointments, and at significantly less cost.
“By simplifying the process and providing accessible solutions, PocketAid aims to increase hearing aid adoption and diminish stigma associated with hearing aids.”
Earlier, in March 2023 WS Audiology launched Vibe self-fitting OTC hearing aids in Australia online and at selected hearing clinics in major cities. They are registered medical devices, connected to a smartphone and controlled with a smartphone app. Within five minutes they can be personalised to a user’s preference and hearing needs, the company website says.
South Australian clinic My Hearing sells Vibe, marketed as a “cheaper, self-fitting hearing aid” manufactured using German technology. My Hearing says: “They suit anyone looking for a more affordable option or individuals who aren’t quite ready to commit to a prescription hearing aid.”
Summerlin Audiology in Perth sells OTC hearing aids but only recommends them after a hearing assessment, saying they have had mixed reviews in America and were originally designed to be a cheaper alternative to traditional hearing aids for ‘first-time’ users with mild hearing issues.
“They have to comply with many safety aspects regarding over-amplification running the risk of further damaging hearing and their fitting may mask a more sinister problem with hearing that could require surgery,” its website states. “Locally, a few models are available in Australia. Most will connect to a smartphone via a dedicated app to allow a quasi-hearing test to be undertaken with the earpieces in the ears. The smartphone then becomes a remote-control device for the OTC aids.
“The lower OTC hearing aid cost does not include any other services or appointments and so creates a dilemma for hearing care practitioners. We do have OTC hearing aids available but would only recommend these after a hearing assessment (to make sure there are no medical contra-indications) and discussion about lifestyle needs. We don’t want to risk a poor fitting and total rejection of hearing aids for the next seven years.”
Audiologist Iain Summerlin told HPA: “Although there have been quite a few views of the OTC entry on our website, there have been very few direct enquiries for these products. We do have patients with hearing levels within the normal range but difficulties hearing in background noise; OTC aids may offer an easy solution when occasional amplification is required. This strategy may also apply to first time users with a mild hearing loss. We have the Vibe from WSA; the ConC 400 from Sennheiser and the iQ buds to offer/discuss as an option to traditional hearing aids for those hesitant to jump into amplification due to commitment issues or costs.”
OTC hearing aids ‘for mild to moderate heating loss or tinnitus’ are available without a script from Hearing Aid Australia shop, Ear & Hearing Australia independent Melbourne audiologists, and manufacturers are selling OTC hearing aids to consumers via brand websites or third-party retailers.
Studies on OTC devices
Two recent studies suggest there’s no difference in overall hearing aid outcomes between users of prescription and OTC hearing aids for mild to moderate hearing loss. However, some authors from both of the studies disclosed relationships with the HearX group, owner of Lexie Hearing which offers OTC hearing aids, and HearX helped fund one study.
The comparative effectiveness research study, published in July 2024 in JAMA Otolaryngology Head & Neck Surgery, “demonstrated self-fit over-the-counter hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss”.
The study of 44 participants found no significant differences between self-reported benefit of a self-fit OTC hearing aid and audiologist-fit hearing aid eight months after fitting.
“OTC may be an effective long-term intervention option for people with mild to moderate hearing loss. These results contribute to the growing body of literature supporting the feasibility and effectiveness of OTC hearing aids,” the researchers wrote.
The previous survey in 2022 of 406 prescription hearing aid users and 250 who used OTC models was published in The American Journal of Audiology. It also concluded there was, “no significant difference for overall hearing aid outcomes” between clinic-prescribed and fitted hearing aids and OTC devices. But for the “daily use” domain, prescription clients reported significantly longer hours of daily use and for the “residual activity limitations” domain, OTC users reported significantly less difficulty hearing in situations where they most wanted to hear better.
However, Dr. Taddei cautions that these studies only examined one OTC product. Since performance and features vary among different devices, he says the results should not be generalised to all OTC hearing aids.
Audiology Australia view
When the FDA ruling came in 2022, Audiology Australia (AudA) issued a document on its consumer hub. This said it supported provision of hearing devices for all people diagnosed, through appropriate clinical consultation, as benefiting from the assistance of a hearing device.
It acknowledged some people may be interested in self-fitting hearing devices as a solution to managing their hearing loss or perceived hearing difficulty and developed a guide to help them understand some of the challenges associated with purchasing, fitting and adjusting a self-fitting hearing device.
“In all cases, AudA recommends the involvement of an accredited audiologist in the diagnosis of hearing loss or a self-perceived hearing difficulty, and in the support of clients, either face-to-face or through teleaudiology, with the adjustment of their preferred hearing device,” it said.
“If the TGA decides to approve for the regulation of a separate category of hearing aids that can be purchased over-the-counter without the involvement of a hearing health professional, the OTC hearing aids will be subject to TGA regulatory requirements for safety, quality and performance, and listed on the ARTG as medical devices.”
This listing would help individuals ascertain which OTC hearing devices were specifically designed for hearing loss and separate these products from personal sound amplifiers, which are not regulated by the TGA and generally not intended for hearing loss.
“If the TGA does not decide to approve for the regulation of OTC hearing aids, individuals in Australia will still be able to purchase and/or import the OTC hearing aids developed for the US market for personal use, either online or through a local supplier,” Auda said.
“AudA understands that self-fitting hearing devices may assist some clients with the self-management of milder hearing loss or with the amplification of sounds in certain situations. The use of self-fitting hearing devices may also represent convenience, autonomy and a financial saving. “
However, AudA recommends that anyone seeking to purchase a self-fitting hearing device considers their requirements carefully and ensures that, where they may need support for the fitting and adjustment of their hearing device, they seek the involvement of a qualified hearing health practitioner.
To safeguard long term hearing health, AudA strongly recommends that an audiologist is involved in the assessment of hearing ability before the purchase of a hearing device, which include self-fitting hearing devices. AudA further encourages clients to take action to ensure that the products that they are purchasing are done so through a reputable supplier after they have sought appropriate advice and diagnosis from an accredited audiologist to ascertain that a hearing device is the best support for their individual circumstances.”
