Can Earbuds Be Hearing Aids in 2026?

Roughly 28.8 million American adults could benefit from hearing aids, and only about one in five who could use them has ever tried a pair. The over-the-counter category was created to remove cost as the barrier. Adding earbuds you may already own to that category is the logical next step, and it is now real. For the full OTC explainer, including when to skip OTC entirely, see OTC vs. prescription hearing aids. For low-cost prescription options, see Costco hearing aids.

The direct answer

Ordinary earbuds are not hearing aids. Personal sound amplification products (PSAPs) are not hearing aids either. Both can make things louder. Neither is authorized to compensate for impaired hearing.

What changed is a new device type: hearing aid software that runs on earbuds you may already own. Once the software is authorized and you complete a self-fitting, those compatible buds are an over-the-counter hearing aid under the same 2022 FDA category that covers dedicated OTC devices sold at a pharmacy.

Two companies now sit in that software category in a way that matters to shoppers:

1. Apple, September 12, 2024: first OTC hearing aid software, Hearing Aid Feature on compatible AirPods Pro.
2. Samsung, FDA decision July 31, 2026 (K261187); company announcement August 11, 2026: Hearing Aid Feature on Galaxy Buds3 Pro and Galaxy Buds4 Pro, U.S. rollout targeted for Q4 2026.

If your buds are not on those compatibility lists, and they do not carry another FDA-authorized hearing aid feature, they are not hearing aids. Turning up transparency mode is not a fitting.

This is not a rewrite of OTC vs. prescription hearing aids. That page is about the two retail categories. This one is about a third object people keep asking about: the $200 pair of buds in the same pocket as the phone.

What Samsung actually got cleared

Samsung Electronics announced on August 11, 2026 that its Galaxy Buds Hearing Aid feature received FDA clearance. Compatible buds can serve as an OTC hearing aid for users 18 and older with perceived mild to moderate hearing loss (Samsung's example of that is difficulty following conversations in noise), without a prescription or clinic visit.

The official FDA record is more specific than the press release.

The July 31, 2026 510(k) letter for K261187 clears a device named Hearing Aid Feature, Class II, product code SCR, regulation 21 CFR 874.3335 (air-conduction hearing aid software). Indications for use: an OTC software-only mobile medical application that amplifies sound for users 18 or older with perceived mild-to-moderate impairment, running on compatible Samsung Galaxy phones and earbud wearables. The user is intended to self-fit it, including adjustments, without a hearing healthcare professional.

The predicate device is Apple's Hearing Aid Feature, DEN230081. Apple opened the software class in 2024; Samsung used the 510(k) pathway to show substantial equivalence in 2026.

Manufacturer materials and the 510(k) summary describe two software pieces: one on the phone (onboarding, self-fitting, settings, safety information) and one on the buds (audio processing and amplification). Samsung says users open the Galaxy Buds menu in Settings, take an about-five-minute Hearing Test (pure-tone, each ear, produces an audiogram), then the Hearing Aid feature applies amplification. The company says the Hearing Test is registered as software as a medical device (SaMD). Fitting uses NAL-NL2. Additional user controls include volume and beamforming.

Samsung's stated compatible hardware for the U.S. and select-market launch is Galaxy Buds3 Pro and Galaxy Buds4 Pro, in Q4 2026. Full support requires a compatible Galaxy phone running One UI 8 or later. Availability may vary by market, model or paired device. The company has not, as of August 23, 2026, published a street price for the software itself; it is a feature on buds people buy as consumer electronics.

Clinical claim in the 510(k) summary, not independently re-run by this site: Samsung reported that APHAB global benefit for a self-fit group was non-inferior to a clinician-fit group (mean difference −1.01; 95% upper confidence bound 5.81). Acoustic numbers in that same summary include a maximum OSPL90 of 111.9 dB SPL with input-controlled compression activated, and full-on gain of 31.5 dB. Those figures come from the manufacturer's FDA filing. They can change with firmware; they are not a review score.

The AirPods precedent, in numbers

Apple's Hearing Aid Feature was the first of this type. FDA authorized it on September 12, 2024 as OTC hearing aid software for compatible AirPods Pro, for people 18 or older with perceived mild to moderate impairment. Users set it up on an iPhone or iPad; hearing levels come from the on-device Hearing Test or an imported audiogram.

FDA said the feature was evaluated in a clinical study of 118 people with perceived mild to moderate loss at multiple U.S. sites. Self-fitting produced similar perceived benefit to professional fitting of the same device, with comparable in-ear amplification and speech-in-noise results, and no device-related adverse events in that study. The pathway was De Novo, which created 21 CFR 874.3335.

Apple's support documentation, updated as recently as August 18, 2026, lists the Hearing Aid feature on AirPods Pro 2 and AirPods Pro 3. An Apple white paper (October 2024) states the feature's maximum output does not exceed 117 dB SPL. Apple's 510(k) comparison table in Samsung's filing lists the predicate's max OSPL90 as 106 dB SPL. Treat those as manufacturer-reported electroacoustic numbers, not a ranking.

Apple also notes the Hearing Aid feature amplifies environmental sound in Transparency mode. Media Assist is a separate setting for music, video, and calls. For the difference between OTC hearing aids and PSAPs (personal sound amplification products, which are not hearing aids), see our PSAP vs. hearing aids guide.

The statute that made both products possible

Congress ordered OTC hearing aids in the FDA Reauthorization Act of 2017. FDA published the final rule on August 17, 2022 (87 FR 50698). It became effective October 17, 2022. Codified in part at 21 CFR 800.30: adults can buy hearing aids without an exam, prescription, or professional fitting if intended for perceived mild to moderate impairment. OSPL90 ≤ 111 dB SPL generally; ≤ 117 dB SPL with input-controlled compression on. Age 18+. Not for severe/profound loss.

The rule did not require OTC hearing aids to be self-fitting, which is why preset devices and software-based devices both exist under one label. It also did not anticipate that consumer earbuds would become the substrate for a regulated medical device, but the rule imposed no form-factor constraints, so nothing blocked it.

Earbuds vs. dedicated OTC vs. clinic-fit prescription

Use market ranges only. Dedicated self-fitting OTC hearing aids average about $500 a pair (roughly $200 to $1,500). Private-pay prescription pairs commonly run $1,400 to $7,000, averaging about $3,400. Earbuds with FDA-authorized hearing aid features fall into the OTC column on regulation and output limits, but their price point reflects their dual use as consumer audio.

Clinic manufacturers already sell earbud-looking hearing aids that are not consumer audio. Examples include Signia Active Pro IX, Signia Active IX, Signia Pure Charge&Go IX, and Phonak Audéo Sphere Infinio. Those are prescription devices, fitted to an audiogram, with no output cap. They look like earbuds, but they are not sold as consumer audio and they are not in the OTC category. Browse the full catalog at hearingaidfinder.org/hearing-aids.

When earbuds-as-hearing-aids are a reasonable first step

An FDA-authorized earbud hearing aid feature makes sense if most of these describe you:

• You notice difficulty mainly in background noise or group conversation, and one-on-one in a quiet room is still fine.
• Your hearing feels about the same in both ears.
• The change came on gradually over years, consistent with age-related loss.
• You have no ear pain, drainage, ringing that started suddenly, or dizziness.
• You are comfortable with a smartphone app, including redoing a setup if the first attempt is off.
• You already own compatible buds or were planning to buy them for consumer audio, so the hearing aid feature is effectively free.
• You want to try amplification without a $3,000 commitment, or you have been putting off treatment for years and need a low-stakes first step.

When earbuds-as-hearing-aids are the wrong tool

These are the conditions the FDA identified as warranting medical evaluation before amplification. Any one of them means see a physician or audiologist first, because the cause may be treatable and amplification may mask something that needs attention.

1. Sudden or rapidly worsening hearing loss, especially within the last 90 days. Sudden sensorineural hearing loss is a medical emergency and treatment outcomes depend on how fast you are seen.
2. Hearing loss in only one ear, or a noticeable difference between ears, of recent onset.
3. Pain or discomfort in the ear.
4. Drainage from the ear in the past 90 days.
5. Dizziness or vertigo, acute or chronic.
6. Visible deformity of the ear, congenital or from injury.
7. Suspected wax blockage or a foreign body in the canal. This one is common and fully reversible, and it is the cheapest hearing "cure" there is.
8. Hearing that fluctuates, coming and going over days or weeks.
9. Severe or profound hearing loss, or the user is under 18. Both are excluded from the OTC category by rule. An output-capped device cannot deliver the gain severe loss requires.

Also consider a professional fitting if:

• Your hearing loss is asymmetric (one ear noticeably worse than the other).
• You struggle to hear even in quiet one-on-one conversation.
• You have bothersome tinnitus that needs clinical management.
• You tried OTC amplification and it simply was not enough.

See our 10 early signs of hearing loss guide for more detail on when to escalate to a clinician.

Global context: the U.S. National Institute on Deafness and Other Communication Disorders reports that about 28.8 million U.S. adults could benefit from hearing aids. The World Health Organization estimates that more than 1.5 billion people globally have some hearing loss, projected toward 2.5 billion by 2050. OTC categories, including earbud-based software, exist to close that treatment gap.

Frequently asked questions