As technology reshapes hearing care, audiologists must protect the patient relationship, interpret new streams of data and adapt to changing models of care.
The hearing aid has always been far more than an amplifier; it is a sophisticated, purpose-built signal processor. What is new is that it is no longer self-contained. It has become a node in an ecosystem of apps, sensors, cloud services and streaming, increasingly performing biometrics, health tracking, communication and even translation alongside its clinical function.
As it evolves into a connected health and communication platform, an uncomfortable question follows: who owns the data? Not who dispenses the box, but who holds the relationship, the data and the trust. The answer is being decided now, and hearing healthcare professionals should be shaping it.
Why now?
Several forces have converged. Populations are ageing, and untreated hearing loss remains one of the largest unmet health needs worldwide [1]. At the same time, consumer electronics, medical devices and digital health have collided. Low-power biosensors, on-chip AI and Bluetooth LE Audio made it possible to pack capabilities well beyond hearing into an all-day wearable. Regulation then caught up: in 2022 the US Food and Drug Administration created a new over-the-counter (OTC) category [2], letting adults with perceived mild to moderate hearing loss buy hearing aids directly, without a professional. To see what changed, it helps to map the categories.
Figure 1: Hearing device categories in the USA.
Hearing device categories
In the USA, the landscape now splits into two lanes (Figure 1). On one side are hearing aids, regulated as medical devices: prescription devices, fitted by a professional for people with any degree of hearing loss; and OTC devices, purchased directly by adults with perceived mild to moderate hearing loss. On the other side are consumer electronics that are not regulated as hearing aids, including personal sound amplification products (PSAPs), intended for people with normal hearing who want to enhance environmental sounds, and hearables such as wireless earbuds and general consumer audio devices. These products can look and behave alike, and PSAPs or hearables are sometimes marketed as hearing aids, making professional guidance important.
Figure 2: Four converging subcategories of OTC hearing aids.
OTC is not one thing. Depending on regulatory classification or form factor, OTC hearing aids fall into three to four categories (Figure 2):
(a) Self-fitting OTC, tuned by the user through an app after a self-test, on a stricter regulatory pathway;
(b) Preset OTC, with fixed, one-size-fits-most programmes;
(c) Software as a medical device (SaMD), where a hearing-aid function is added to general-purpose consumer earbuds by cleared software, led by the Apple AirPods Pro Hearing Aid Feature; and
(d) Hearing glasses, dedicated eyewear with built-in open-ear amplification such as Nuance Audio.
These four are not sorted on a single axis: (a) and (b) differ by how the device is fitted (self-test versus preset) as well as by regulatory category; (c) by what it technically is, a hearing aid function delivered as software on ordinary earbuds; and (d) by its physical form (eyewear). Only (c) is SaMD, and it is itself self-fitting; each category nonetheless blurs the line between medical device and consumer gadget further.
Elsewhere the picture is simpler. Most countries have no formal OTC framework: in practice there are prescription hearing aids, regulated as medical devices and professionally fitted (in the EU under the Medical Device Regulation, in the UK largely through the NHS), and a single, loosely defined category of unregulated direct-to-consumer (DTC) devices sold online. This DTC category exists in most markets but offers far fewer, less consistent options than in the US and receives little professional attention.
From device to connected health platform
The deeper shift sits beneath these categories. The hearing aid has become the best-positioned wearable one can own. Worn in the ear all day and paired to the smartphone, it is real estate no smartwatch can match. Manufacturers have used that position to add functions well beyond hearing: sensors that detect falls and track activity, heart rate and gait, and algorithms inferring social engagement, listening effort and markers relevant to healthy ageing and cognition. Devices classify the acoustic scene with deep neural networks, translate speech in near-real time and stream audio over LE Audio and Auracast [3]. Firmware updates arrive over the air, fittings are refined remotely by teleaudiology, and data flow to cloud dashboards and general health platforms. No longer an appliance a professional dispenses and forgets, the hearing aid is a connected, data-generating platform that couples hearing with communication and wellbeing, and keeps a continuous relationship with the user long after the clinic.
Who owns the data?
This is what makes the ownership question urgent and genuinely contested. Manufacturers own the hardware and firmware; consumer-technology companies own the software, the operating system and the data pipe. A profession that defines itself around the hearing aid risks being reduced to troubleshooting a device someone else designed, sold and monitors. The same platform shift can go either way, depending on how the profession positions itself (Table 1).
The case for hearing healthcare professionals to own this space is simple: no one else can. The device alone does not guarantee a good result: many users do not reach optimal outcomes without support to fit and fine-tune their devices, and manage problems and adjustment over time [4,5]. Device quality also varies widely, especially across OTC and DTC products, and consumers are rarely able to judge which suits them, a gap the audiologist is well placed to close [6]. The audiologist alone understands the auditory system, diagnoses and manages ear disease, clears the medical red flags an app cannot, verifies real-world outcomes, rehabilitates communication and can now also interpret the hearing and health data these platforms generate. Manufacturers optimise devices; platforms optimise engagement; only the audiologist optimises the outcome with patients.
The typical patient journey has already changed. In the past it began with a symptomatic person coming to the clinic to be tested and then fitted with a device; today someone may walk in having already bought a device online, for themselves or a partner, with no prior testing [7]. Seizing that role requires a change of identity, from hearing-aid expert to hearing expert. A hearing-aid expert sells and services a product, and sees OTC and consumer earbuds as threats. A hearing expert treats each innovation as another route to better hearing and embraces it: screening the person who walked in with earbuds, validating a self-fit, taking the complex case the algorithm abandons and interpreting the data the device produces. The task is to facilitate the patient’s needs across the whole journey, device-agnostically, meeting people wherever they enter, from a modest preset aid to a premium prescription fitting, and staying with them. None of this fits neatly into today’s delivery models. Reaching these users demands innovation and reform in how hearing care is delivered: unbundled and hybrid services, teleaudiology and outcome-based models built around the patient rather than the device.
The platform shift is not optional, and it is not slowing down. If the profession embraces the innovation, claims the data-interpretation and care-coordination layer, and helps write the rules for data ownership and consent, it will not merely survive this transition; it will lead it. Own the patient relationship and the expertise. Let manufacturers keep the box.
References
1. World Health Organization. World Report on Hearing. Geneva, Switzerland. 2021.
www.who.int/publications/i/item
2. US Food and Drug Administration. Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. Final rule. Fed Regist. 2022.
www.federalregister.gov/documents/2022/08/17/
2022-17230/medical-devices-ear-nose-and-throat
-devices-establishing-over-the-counter-hearing-aids
3. Lesica NA, Mehta N, Manjaly JG, et al. Harnessing the power of artificial intelligence to transform hearing healthcare and research. Nat Mach Intell 2021;3(10):840–9.
4. Manchaiah V, Swanepoel DW, Sharma A. Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. Front Aging 2023;4:1105879.
5. Ricketts TA. Potential Roles of Audiologists Supporting Patients’ OTC Hearing Aid Journey. Semin Hear 2025;46(1):10–8.
6. Manchaiah V, Taddei S, Bailey A, et al. A novel consumer-centric metric for evaluating hearing device audio performance. Front Audiol Otol 2024;2:1406362.
7. Taylor B, Manchaiah V. Pathways to care: how innovations are decoupling professional services from the sale of hearing devices? Audiology Today 2019;31(5):16–24.
[All links last accessed October 2026]
Declaration of competing interests: DWS has shares in LXE Hearing and has served as consultant for them.
