Published on Jun 05, 2026
In 2022, the Food and Drug Administration finalized a rule expected to increase competition in the hearing aid market by giving patients with mild-to-moderate hearing loss access to over-the-counter hearing aids, a potentially cheaper alternative to expensive prescription devices. But only 5.7% of people who report hearing issues have adopted over-the-counter products, a 2025 survey found. Meanwhile, the market for hearing […]
In 2022, the Food and Drug Administration finalized a rule expected to increase competition in the hearing aid market by giving patients with mild-to-moderate hearing loss access to over-the-counter hearing aids, a potentially cheaper alternative to expensive prescription devices.
But only 5.7% of people who report hearing issues have adopted over-the-counter products, a 2025 survey found.
Meanwhile, the market for hearing aids remains tightly controlled by five large device manufacturers that—often unbeknownst to patients—continue to shape pricing and access via their vertical integration with audiology clinics, insurance benefits managers, and practice management groups, competition advocates and audiologists told The Capitol Forum.
“[T]he over-the-counter (OTC) hearing aid rule created a new device category, but it did not create a hearing healthcare access system,” Dr. Amyn Amlani, professor and chair of the Department of Communication Sciences and Disorders at the University of Oklahoma Health Sciences Center and immediate past president of the Academy of Doctors of Audiology, told The Capitol Forum in a written statement. “Coverage gaps, consumer confusion, limited self-screening infrastructure, workforce constraints, and persistent information asymmetry remain largely unchanged.”
What’s more, “The Big Five, their monopoly has really remained entrenched in the last several years, even after the law [the Over-the-Counter Hearing Aid Act] was implemented,” Emma Freer, senior policy analyst for health care at the American Economic Liberties Project, told The Capitol Forum.
Prices for prescription hearing aids remain high; according to the latest survey from Hearing Tracker, the average patient is paying over $2,600 for a single pair. And across the brands sold by the five largest manufacturers, average prices range from slightly above $1,000 to more than $4,000.
The so-called “Big Five” manufacturers—WS Audiology, Demant (CPH: DEMANT), GN (GPH:GN), Starkey, and Sonova (OTCMKTS: SONVY)—control an estimated 90% of the global market and 84% of the U.S. market for hearing aids, AELP reported. All except Starkey are headquartered abroad, and all five companies manufacture and sell multiple hearing aid lines.
Four of the five operate insurance intermediaries called “hearing benefits managers” (HBMs), which contract with both commercial and Medicare Advantage plans to help determine which providers are in-network and which hearing aids are covered.
In Freer’s opinion, manufacturer ownership of HBMs may create conflicts of interest by allowing the companies to “orchestrat[e] patient steering to their products” and “steer patients to affiliated clinics and also deny business to independent clinics or unaffiliated clinics.”
The “Big Five” companies also all own and operate networks of retail clinics in the U.S.
“When a manufacturer owns the clinic dispensing those devices, it captures revenue at both ends of the transaction—device sale and professional service—while also governing which products are recommended, how they are priced, and how patients are retained over time,” Amlani said.
Sources told The Capitol Forum that the extent of consolidation and vertical integration in audiology not only raises concerns about manufacturers steering patients towards their own products and clinics—it also disadvantages independent providers.
“The lack of competition that we’ve had has caused a huge issue because we don’t have anybody to choose from and then we depend on them for product,” an independent audiologist told The Capitol Forum. “They’re able to give significant discounts based off of volume of hearing aids.”
Compared to independent audiology practices, clinics funded or owned by a large hearing aid manufacturer have much better margins, the audiologist said: “A Hearing Life clinic, they only have to pay what it took and make a hearing aid, so they get more profit than we do,” they said, referencing William Demant’s practice group.
AELP’s Freer said “the parallels are chilling” between the hearing aid industry and the prescription drug industry. She said vertical integration in audiology mirrors the business models of the “Big Three” pharmacy benefit managers (PBMs), health insurance middlemen that have attracted scrutiny in Congress and a lawsuit from the FTC, and the largest drug wholesalers and their group purchasing organizations (GPOs), which have also come under fire for integrating with providers.
Yet consolidation continues: Amplifon (BIT: AMP), an Italian company that is reportedly the largest hearing aid retailer globally, is set to acquire the hearing business of GN, a “Big Five” manufacturer, for $2.64 billion by the end of 2026. Amplifon already operates a retail network and hearing benefits manager in the U.S.
The Capitol Forum reached out to WS Audiology, Demant, Starkey, Sonova, GN, and Amplifon for comment; their responses are detailed below.
U.S. hearing aid market remains riddled with perverse incentives, sources say. The FDA’s rule, finalized in 2022 but enabled by the 2017 Over-the-Counter Hearing Aid Act, created a new category of FDA-regulated devices: over-the-counter hearing aids.
To be sure, there is some indication that uptake of over-the-counter hearing aids is on the rise. The same 2025 survey that identified the 5.7% over-the-counter adoption rate also found that 70% of first-time buyers are choosing over-the-counter hearing aids—and that overall hearing aid adoption rates are increasing.
But the rule hasn’t shaken up the market as much as expected for several reasons, including the fact that fee-for-service Medicare doesn’t cover hearing aids, and the FDA’s rule only extends to people with mild-to-moderate hearing loss, sources told The Capitol Forum.
The over-the-counter hearing aid landscape also hasn’t been as competitive as some expected, in part because four of the “Big Five” hearing aid manufacturers (Demant being the exception) launched their own over-the-counter hearing aid brands around the time of the rule’s implementation.
“What they did is they bought an OTC hearing aid company so that people would get hooked on that OTC, and then when they got tired of that OTC or the OTC didn’t work, they would go right to that hearing aid company,” Dr. Barbara Weinstein, an expert in hearing loss in older adults who founded the audiology doctorate program at CUNY, told The Capitol Forum.
Several over-the-counter hearing aid brands have left the market since the FDA passed its rule; in 2024, for instance, GN discontinued its Jabra Enhance Plus self-fitting over-the-counter hearing aids, and in April 2026, Sony discontinued its over-the-counter hearing aid line. Amlani noted that there has been stiff pricing competition from Apple’s (AAPL) FDA-authorized hearing feature in the AirPods Pro headphones.
“Whether this represents a genuine population health advance or a further erosion of the regulated hearing aid market’s viability for traditional manufacturers remains an open empirical question—but it warrants recognition as the OTC era’s most consequential access development to date,” Amlani said.
Consumers have been left to navigate a prescription market shaped by vertical integration, sources said.
“[V]ertical integration is not simply a business strategy; it is a structural force shaping who controls access to hearing care, how prices are set, and whether patients receive care organized around clinical need or device distribution,” Amlani said.
Weinstein noted that consumers, including older adults, aren’t always clear on the ownership structures at play. “The private practitioner doesn’t tell the customer that [the clinic] is owned by a hearing aid manufacturer,” Weinstein said. “The most important thing is the quality of life and the best product for the person, and I think that that gets lost.”
Also, “it looks like you’re being able to compare hearing aids [at a manufacturer-owned clinic], but it’s really the same hearing aid company with different hearing aid names,” Weinstein said.
Amlani said that because the payment for clinical fittings, counseling, and follow-up care is traditionally bundled in audiology, “acquiring clinics extends that control downstream into the patient encounter itself.” The bundled pricing model also “leaves independent practices exposed when manufacturer-owned retail operations absorb the professional service component as a loss leader to retain the device transaction,” Amlani said.
Sources noted that direct ownership isn’t the only way the largest hearing aid manufacturers influence the practice of audiology—they may also finance independent clinics. As the independent audiologist who spoke to The Capitol Forum put it, the largest manufacturers “basically fund the loans of a lot of these practices.”
Some of the largest manufacturers run practice management groups for independent clinics; Demant and GN, for instance, promise their members negotiated group discounts. According to Freer, this raises questions about how much influence the manufacturers have over independent clinics’ purchasing patterns.
“Yet another way that these manufacturers can exert control on audiologists is by locking them into anti-competitive buying contracts,” Freer said, comparing that conduct to the “dominant GPOs in how they manage their supply contracts with hospitals and other providers.”
While traditional Medicare doesn’t cover hearing aids, roughly 97% of MA plans offer supplemental hearing benefits, which may be managed by manufacturer-affiliated companies. Unlike the other “Big Five” hearing aid makers, which own HBMs, Sonova sold its HBM to UnitedHealthcare (UNH) in 2018. However, the company’s Relate hearing aids still feature heavily in the insurer’s Medicare Advantage plan offerings.
Some sources alleged that the hearing “benefits” offered by insurance plans are often just manufacturer-funded discounts.
The independent audiologist who spoke to The Capitol Forum recalled a time when they weren’t getting many UnitedHealthcare patients; they said the reason was that the largest manufacturers were “basically getting all the referrals, and then they were switching them over to Phonak or Oticon [brands owned by Sonova and Demant] and upselling them.”
The audiologist said they’d faced similar issues with Advanced Hearing Providers, a workers’ compensation claims manager affiliated with Demant, which makes Oticon hearing aids.
“Basically, if you signed up to AHP [Advanced Hearing Providers], which is owned by Oticon, they’re going to fill the workman’s comps referrals to those clinics,” the audiologist said. “They were getting funneled to Oticon clinics that were retail clinics or ones that had Oticon loans.”
Moreover, “[r]eimbursement rates offered through TPA [third-party administrator, or hearing benefits manager] channels are typically below market, which is financially untenable for many independent practices, effectively narrowing the provider network to manufacturer-affiliated and corporate retail outlets,” Amlani said.
Consolidation in audiology has attracted some attention in Congress. In a 2022 letter, Sens. Elizabeth Warren, D-MA, and Chuck Grassley, R-IA, raised concerns about the largest hearing aid makers weakening the final over-the-counter hearing aid rule to protect their own interests, including the ability to “steer consumers into manufacturer-owned or affiliated retail clinics.”
Several bills that would expand Medicare coverage to hearing aids have been introduced in recent years, and in 2024, Sen. Warren and Rep. Kevin Mullin (CA-15) called on the FDA to investigate “locked” hearing aids, where the device is programmed such that it can only be repaired by the manufacturer or an affiliated clinic.
Sen. Grassley, who along with Warren spearheaded the legislation that led to the FDA’s over-the-counter hearing aid rule, provided the following statement: “I was proud to move the bipartisan Over-the-Counter Hearing Aids Act through Congress to improve access to high-quality and affordable hearing aids. After years of pressing the Food and Drug Administration (FDA) to finalize rules, I’m glad consumers have access to safe, effective, accessible and affordable hearing aids over-the-counter. This law is providing Americans across the country with an affordable option to help overcome hearing loss.”
Manufacturers, retailers weigh in. Starkey and WS Audiology did not respond to requests for comment. GN declined to comment; Demant referred The Capitol Forum to the U.S. Hearing Industries Association (HIA).
HIA shared the following statement:
“Hearing loss is a unique, individualized health condition, and many consumers continue to prefer professional guidance to rule out underlying medical conditions that may be causing it, understand their specific level of hearing loss, and evaluate treatment options to achieve the best possible outcomes. According to MarkeTrak 2025 research, almost eight in ten OTC hearing aid owners who did not receive professional assistance believe that assistance from a hearing care professional would have been beneficial.
Consumers today have more choices than ever, with innovative hearing aid solutions. Prescription hearing aids are available across a wide range of technologies and price points, ensuring that individuals can find an option that fits their unique hearing health needs, lifestyle, and budget.
As the market evolves, licensed hearing care professionals continue to play a crucial role. Through comprehensive evaluations, personalized recommendations, fitting, programming, and follow-up support, professional care optimizes the benefits of hearing technology for patients across the United States.”
Demant also contributed a comment of its own:
“The U.S. hearing care market is dynamic and highly competitive, with a wide range of public and private providers, various distribution channels, and increasing availability of different product categories. Hearing aid users today have more options than ever before. Hearing care professionals, whether in company-owned or independent clinics, are qualified professionals, trained to advise on solutions based on patient needs.
Demant’s wholesale and retail activities operate as separate businesses and act independently in the market.
The Demant Group owns multiple high-quality hearing aid brands, which are widely offered across the market and in our own clinics.
In our clinics, we support the hearing aid user’s entire journey to better hearing by ensuring that they are diagnosed with the best equipment, their hearing loss is treated with the most advanced hearing aids, and they are met with the highest level of specialist care.
As a general principle, we do not comment on specific customer relationships or individual agreements. Pricing and commercial terms are determined independently, reflecting a range of factors including market conditions, product innovation and customer needs, and are conducted in a fair and compliant manner.”
A Sonova spokesperson also weighed in:
“At Sonova, our focus is on improving patient outcomes and expanding access to hearing care. We believe that vertically integrated models are one avenue to support this by enabling a closer connection between innovation, clinical expertise, and direct patient feedback. This helps ensure that real-world patient outcomes continuously inform the development and improvement of our solutions.
Hearing care is not a one-size-fits-all solution. Successful treatment depends on a combination of advanced technology, professional fitting, and ongoing support. This level of care requires close collaboration between research, product development, and hearing care professionals, always with the aim of delivering the best possible outcome for the individual patient.
Patient choice is fundamental. A broad and evolving range of options—including over-the-counter and professionally fitted solutions—is important to address different needs, preferences, and levels of hearing loss. We see these approaches as complementary in helping more people access appropriate care.”
Finally, Amplifon responded to questions about the proposed GN acquisition:
“Amplifon operates in a highly competitive and fragmented healthcare retail environment, both globally and in the United States, which includes a wide range of independent providers, multi-brand retailers, and alternative distribution channels. While Amplifon is a leading global hearing care retailer, its presence in the U.S. reflects this diverse and evolving market.
The proposed acquisition of GN Hearing remains subject to customary regulatory approvals and closing conditions. GN Hearing primarily operates in the United States as a manufacturer and through independent retail networks, and the transaction would bring together complementary capabilities across manufacturing and retail within a market that includes numerous participants at both the provider and manufacturing levels. The transaction is not expected to alter the competitive dynamics of the U.S. hearing care market, which includes a range of manufacturers, independent providers, and distribution channels and continues to evolve with new entrants and offerings. The U.S. hearing care market will remain characterized by significant competition across retail, clinical, manufacturing, and emerging direct-to-consumer channels. Customers, healthcare professionals, and payors will continue to have access to multiple competing manufacturers and retail providers following completion of the transaction.
With respect to managed care and hearing benefits, Amplifon’s position in the United States has evolved in recent periods, and no managed care or hearing benefits management business is included in the proposed transaction. As a result, the transaction is not expected to affect competitive dynamics in that segment.
Following the completion of the transaction, Amplifon intends to progressively introduce GN Hearing products into its retail networks, alongside products from other leading manufacturers, ensuring the continuous coverage of the full spectrum of hearing needs.
The U.S. hearing care market continues to evolve with the introduction of new products, technologies, and channels, including over-the-counter options and digital health solutions. Amplifon believes that combining its clinical expertise and patient care capabilities with GN Hearing’s technology and innovation has the potential to enhance the patient experience and support continued access to high-quality hearing care solutions. The transaction is expected to support continued investment in innovation, product development, and patient-focused services, while preserving competitive choices available to consumers and healthcare providers.
Amplifon operates within established regulatory frameworks and is committed to compliance with applicable competition and healthcare laws in all markets in which it operates.”
