OTC Hearing Aids: Who Can Buy Them, Cost and FDA Records

Who can buy OTC hearing aids, and where

The FDA rule, 21 CFR 800.30, sets the category: an air-conduction aid for a person age 18 or older with perceived mild to moderate hearing impairment. "Perceived" means you judge your own hearing, so buying one needs no test result. If you are shopping for mild hearing loss, this is the sales category written for it, and it reaches up to a moderate loss.

The aid can be sold "to consumers through in-person transactions, by mail, or online" with no licensed person involved. Sale to anyone younger than 18 is prohibited.

The box carries required information you can read before you pay. It must declare an aid that is used or rebuilt, and it must carry advice to seek professional services. For a professional fitting instead, audiologist vs hearing instrument specialist compares the two licenses.

Where to buy OTC hearing aids: the stores we read

FDA says you can buy OTC hearing aids "in person at a store or through an online retailer", and also "from a hearing health care professional". What a store carries changes from week to week, so these are dated readings, with no price and no promise of stock.

• Costco. In October 2026, its Hearing Aid Center page showed four brands with a price: Philips, Jabra, Rexton and Sennheiser. The page says licensed hearing instrument specialists run the hearing test, so check whether a listing is sold over the counter or fitted. See Costco hearing aids.
• Walmart. The same month, its category page read "OTC Hearing Aids in Home Health Care(67)". The text named no seller, and several cards were marked Sponsored, so the order is no ranking. See Walmart hearing aids.
• Sam's Club. A Jabra Enhance Select product page, read for the Secaucus club, showed shipping out of stock and pickup as "Check clubs", with licensed hearing professional services included for 45 days after purchase. See Sam's Club hearing aids.
• Brand sites. Oricle, ELEHEAR and Jabra Enhance sell on their own sites, as the prices below show.

CVS and Walgreens hearing aids: what their own pages show

CVS sells OTC hearing aids in its stores and online, by its own account: "CVS has crafted a full suite of OTC Hearing Aids available in stores and online."

What the CVS.com page listed. On November 7, 2026, its Hearing Aids category page showed 4 products. Among them: the Audien Atom Pro 2 Rechargeable, a hearing aid, and 2 MSA Sound Amplifier packs, a twin and a single. An amplifier on a hearing aid shelf is not proof of a hearing aid, so check the box: FDA's rule puts the marks "OTC" and "hearing aid" on the main panel of an OTC hearing aid. The page also warns that prices may vary from online to in store, so we print none here.

The terms CVS states. Its FAQ says no hearing test is needed before you buy, and that OTC aids are meant for adults with mild to moderate hearing loss only. Opened and used hearing aid products "may be returned within 60 days of ordering the item for a full refund." Each OTC model it sells is adjusted in 1 of 2 ways: preset listening modes, or a smartphone app.

The range CVS wrote down. Its buying guide, updated in February 2025, says its hearing aids "range from about $200 to $1,000." That is the retailer's own range at that date, not a reading of today's shelf.

Walgreens. Its terms of use bar automated collection from its site, so this page holds no dated reading of its shelf yet.

Best Buy, Target and other chains whose shelves we cannot read

Target's terms of use bar data extraction and scraping tools, and the terms of the electronics chain in Jabra's quote below bar copying and scraping. So this page holds no dated reading of either shelf: no model list, no price and no stock. Those wait for a reading by hand.

Retailers in Jabra's terms. Jabra Enhance writes that "Hearing aids purchased through third-party retailers such as Amazon, Best Buy, and Walmart are subject to the retailer's return policy". So the return terms are the store's, not the brand's direct trial. In a Google search we captured on November 7, 2026, that chain's own result was a category page whose title named "Hearing Aids & Amplifiers". A sound amplifier is not a hearing aid: FDA's rule puts the marks "OTC" and "hearing aid" on the main panel of an OTC hearing aid, so check the box.

Target. In the capture for "target hearing aids" the same day, the first two results were Target search pages titled "Eargo Hearing Aids | Explore Options & Prices" and "Rechargeable CIC Hearing Aids". A search page title does not show that a store has an aid on its shelf, so ask your store whether it has hearing aids in store. Eargo 5 and Eargo 6 hold 510(k) K221698, decided on December 21, 2022, in the self-fitting list further down; that file names the devices, not a Target listing or a store.

Neither chain changes the Medicare rule: Original Medicare does not cover hearing aids, and a Medicare Advantage plan pays what its own terms set, as the payment section below explains.

What OTC hearing aids cost

The federal figure is a reported range. GAO's report GAO-24-106854, dated May 7, 2024, says OTC hearing aids "can range from around $200 to over $1,000", against $1,000 to $6,000 per pair for prescription aids. GAO relays that range from an article in The Hearing Journal (Feb. 2023); it is neither an average nor a GAO survey.

Brand readings show how wide the market runs, starting below GAO's floor. In October 2026, Oricle listed the Oricle 2.0 at $149.99 for two aids with a charging case. In November 2026, ELEHEAR showed the Beyond Pro at $599 for a pair, and the card left the charger and service open. In October 2026, Jabra Enhance listed the Select M1 at $1,195 a pair, and that reading left the charger and service open.

These are three single readings chosen to show the spread, so check the seller's page before you buy. For more on low prices, see affordable hearing aids; for prescription and Medicaid figures, see hearing aid costs.

How to compare OTC hearing aids before you buy

We publish no ranking of OTC hearing aids: no model went through a test of ours, and the records we could collect don't compare every model on equal terms. Before reading any lab result, we fixed four things you can document for one named model:

• FDA identity. The exact model name in an FDA record, from the tables here or Devices@FDA.
• Manual. The one written for that model, since a family name can cover several products.
• Return terms. The federal rule requires a return policy notice on the outside package and sets no trial length.
• Service terms. Who handles repairs, for how long, and what happens if the app goes away.

A missing document is a question for the seller, not a defect in the aid. Which aid suits your hearing is for you and a hearing care professional to judge: see how to choose a hearing aid.

In October 2026, ELEHEAR's return policy refunded undamaged products "within 45 days of purchase" and said trial terms elsewhere "may vary by retailer". Its warranty covers one year for products bought "through authorized channels". More: ELEHEAR hearing aids.

HearAdvisor publishes a lab SoundScore and grade for named models. Its about page, read on October 31, 2026, says its funding includes public testing fees, private laboratory work, badge licensing, paid video packages and affiliate commissions. Those results are HearAdvisor's, unchecked by us, and not FDA findings.

Vevo. On November 7, 2026, an openFDA GUDID search for the name Vevo under the hearing aid codes QUF, QUG, QUH and OSM returned no record. That is no finding against any product sold under that name: we could not tie the name to a hearing aid record. Before you pay for an aid sold as Vevo, read the maker and the model printed on the box and look them up in FDA's database. This page shows no Vevo price.

Hearing aids for mild hearing loss: what the rules let us say

No FDA list ranks hearing aids for mild hearing loss, and we publish no ranking of our own. What the rule settles is the category: 21 CFR 800.30 writes OTC aids for a person age 18 or older "to compensate for perceived mild to moderate hearing impairment". Mild loss sits inside that category, and moderate loss is its ceiling. A loss you judge greater than moderate falls outside the OTC category as written.

Inside the category, a claim that one aid suits mild loss comes down to documents you can check for that model: its FDA product code (the three codes are described below), the return policy notice and the control platform its outside package must state, and who services it. Whether you need an aid at all, and which one fits your hearing, are questions for a hearing care professional: see how to choose a hearing aid and what a hearing test costs.

Basic, wireless or self-fitting: the three FDA categories

FDA files OTC aids under three product codes, shown in the first table. Two of them are exempt from premarket notification, the 510(k) file, within the limits FDA sets in its rules. QUF covers standard air-conduction aids. QUG covers aids with wireless technology, which is where a Bluetooth aid fits unless it also lets you program it yourself.

The third code, QUH, covers aids with software that lets you program them yourself. FDA limits this code to the 510(k) route, and the special controls for this class start with clinical data evaluating the self-fitting strategy. Every code still has to meet the labeling and output rules in 21 CFR 800.30.

As of openFDA's October 19, 2026 update, 78 firms held listings under QUF, 82 under QUG and 21 under QUH. A listing is a firm's filing. FDA says wording such as "FDA Registered" "may be used to mislead you", and asks whether it means approved or cleared: "The short answer is NO."

The self-fitting 510(k) decisions on record

The second table lists the 10 decisions openFDA files under QUH, by date. All 10 carry the outcome "Substantially Equivalent". Use it as a lookup: it says which file names a device, and it says nothing about how a device performs.

A model missing from the table can still be in order. It may be sold under one of the exempt codes, or hold a 510(k) filed under a different code: a QUH listing for Enhance Plus cites K213424, which sits outside this list. To check a device yourself, search its name or its company in FDA's Devices@FDA database, which FDA describes on its page about registration wording.

Retail brand names need the same care. A search for Nebroo in FDA's listings returns one entry, "Nebroo hearing aid: F703A", filed by Austar Hearing Science & Technology (Xiamen) Co., Ltd under the 510(k)-exempt code QUF. That is a listing, not a clearance. We could not match it to the model names on sale, which is no finding against those models.

HP Hearing PRO. The self-fitting aid sold under the HP brand has a GUDID record, model NU320-02 (device ID 00850000562004), labeled by NUHEARA LIMITED under QUH, with the OTC flag and the status In Commercial Distribution. The record cites K221064, one of the decisions in the table, and FDA's decision letter gives the trade name as "Nuheara IQbuds 2 PRO Hearing Aid". The HP model and the Nuheara IQbuds2 PRO thus sit on the same 510(k) file. This page shows no HP price: it waits for a reading by hand.

Hearing aid earbuds and sound amplifiers: what FDA's records show

Earbuds reach FDA's records by different routes, listed in the last table. Jabra Enhance Plus and Nuheara IQbuds 2 PRO each have a file whose summary describes earbuds. Apple and Samsung hold files for software named Hearing Aid Feature, under product code SCR rather than the three OTC codes. Apple's file describes firmware on the AirPods Pro 2. Samsung's summary gives Galaxy Buds3 Pro and the Samsung Galaxy S23 as examples, not a full list.

Each file covers what it names, not the rest of a maker's earbuds, and it doesn't show that a product is on sale today. A name search with no result doesn't show a lack of authorization.

Personal sound amplifiers, or PSAPs, are a different product. In the rule that created OTC hearing aids, FDA describes a PSAP as "an electronic product intended for non-hearing-impaired people to amplify sounds in certain environments", and warns that the PSAP name alone "does not remove a product from device regulation" if, for example, the labeling claims to compensate for hearing loss. The OTC rule doesn't cover them, so check which of the two a listing is selling. We hold no PSAP price we can publish.

Bose hearing aids: two files under a prescription code

Bose's two FDA files sit under product code QDD, which openFDA names "Self-Fitting Air-Conduction Hearing Aid, Prescription", regulated at 21 CFR 874.3325. DEN180026, the Bose Hearing Aid, was granted through FDA's De Novo route on October 5, 2018. K211008, the Bose SoundControl Hearing Aids, followed on May 5, 2021. Both name Bose Corporation as applicant.

QDD is therefore a prescription code, separate from the three OTC codes in the first table. An authorization doesn't show that a model is still sold. FDA's device identification database (GUDID) lists the Bose SoundControl Hearing Aid as Not in Commercial Distribution since October 17, 2022, while the Lexie B1, Powered by Bose, labeled by hearX Group, is listed as In Commercial Distribution. Neither status says who supports a device, so ask the seller who services a Bose-branded aid before you pay; the next section shows what can happen to support when a brand closes.

LINNER and Cearvol OTC hearing aids: what FDA's device records show

FDA's GUDID database identifies a device and the company that lists it. A record is not a clearance, and it says nothing about how an aid performs or whether a store stocks it.

LINNER. On November 7, 2026, an openFDA GUDID search on Guangdong Transtek Medical Electronics Co.,Ltd under the three OTC product codes returned two records, both model Nova, both under QUG with the OTC flag and the status "In Commercial Distribution". Neither record names Saturn or Clarity, model names that appear in search results for LINNER's OTC CIC aids for seniors. LINNER model names are not interchangeable: read the exact model on the package before you attribute an FDA category, a trial or a price to a Saturn or Clarity listing. Both Nova records, with their device identifiers, are in the LINNER Nova section of our Nova hearing aids page. For seniors, Medicare's rule is in the payment section below.

Cearvol. A GUDID search the same day on SHENZHEN CANNICE TECHNOLOGY CO.,LTD, brand Cearvol, returned six records: Nano, Nano 2, Wave, Wave Lite, Diamond X1 and Liberte. All six carry product code QUG, the OTC flag and the status "In Commercial Distribution". QUG is the wireless OTC code described above, and none of the six records lists the self-fitting code QUH. Cearvol's terms bar crawling and scraping, so we print no Cearvol price or return term from its site; those wait for a reading by hand. Where HearAdvisor publishes a lab result for a Cearvol model, that result is HearAdvisor's, to read with the funding statement in the comparison section above.

Go Prime, Sharper Image, Sontro and other OTC brands: FDA's records

The same check works for more brand names sold as OTC aids. Each record below comes from an openFDA search made on November 7, 2026, in GUDID unless we name FDA's registration and listing database. It identifies a device or a firm's filing; it is not a clearance, a performance result or a store's stock.

Go Prime. One record, brand Go Prime - Beige with model Go Hearing (device ID 00850022464591), is labeled by HEARX GROUP (PTY) LTD under QUF, the standard OTC code, with the OTC flag. Its status reads "Not in Commercial Distribution", so a Go Prime on sale today may carry another record: compare the device ID printed on the box.

BJ's and Audien. Search results for BJ's hearing aids, read the same day, showed a BJ's Wholesale Club listing titled "Audien Hearing Atom Pro 2 Bundle Kit". BJ's terms bar data gathering by robots, so we read no BJ's page and show no BJ's price or stock. In GUDID, the Atom Pro 2 (device ID 00860009028043) is labeled by Budget Hearing Aids, LLC under QUF and marked In Commercial Distribution. Its OTC flag reads false, as filed, even though QUF is an OTC code. More on the brand: Audien hearing aids.

Sharper Image. Two records under the Sharper Image brand, models JH-D26AT (device ID 06971094538332) and JH-A26D (device ID 06971094538493), are labeled by Huizhou Jinghao Medical Technology Co., Ltd under QUF, with the OTC flag and the status In Commercial Distribution. FDA's classification lists QUF as 510(k) exempt. Neither record carries the word Smart, so match the model printed on the package of a Sharper Image Smart listing to one of these two before you attribute an FDA record to it. Sharper Image prices and store item numbers wait for a reading by hand.

EarCentric. In GUDID, the EarCentric RIE 400 (device ID 06945936703424) is labeled by Xiamen New Sound Technology Co., Ltd. under ESD, a code openFDA names "Hearing Aid, Air-Conduction, Prescription", and is marked In Commercial Distribution. Its OTC flag reads false and its prescription flag reads false, as filed. In FDA's registration and listing database, Xiamen NewSound Technology Co., Ltd lists EasyCharge and EasyCharge Pro, among other names, under QUF.

Otofonix. FDA's registration and listing database holds two listings named "Behind-The-Ear Hearing Aid (Otofonix)", both from Austar Hearing Science & Technology (Xiamen) Co., Ltd.: one under ESD, one under QUF. A listing does not say which code a model sold online carries, so look for the OTC mark on its box.

V03B Pro. Searches for V03B in FDA's 510(k), registration and listing, and GUDID databases returned no record. That does not show the product does not exist, nor what its FDA status is: read the maker and the model printed on the box and look them up in FDA's database.

Sontro. K231550, the Sontro OTC Hearing Aids (AI) of Soundwave Hearing, LLC, is in this page's table of self-fitting 510(k) decisions. Among the GUDID records of Soundwave Hearing, LLC, two name Sontro: model 990011-SWH (device ID 00850016231116) and model 990035-SWH (device ID 00850016231109), both under QUH, the OTC flag reading true and the status In Commercial Distribution. Seller prices wait for a reading by hand.

Core One. Among the GUDID records under the brand Ceretone, labeled by Audicon Corporation, are Core One Pro (device ID 00850065321301) and Core one (device ID 00860010331095). Both are under QUF, the OTC flag reading true and the status In Commercial Distribution. This page reprints nothing from the Ceretone site: prices and return terms wait for a reading by hand.

Returns, warranty and what happens when a brand closes

FDA's OTC hearing aid regulations "do not require manufacturers to provide a warranty". The rule does require a notice of the manufacturer's return policy on the outside package, and the box must say whether a mobile device or other non-included control platform is required. Read those two lines before you pay, because they decide what you can do if the aids stop suiting you or the app goes away.

On July 15, 2026, LXE Hearing, Inc., the company behind Lexie, and related companies including Eargo, Inc. entered an assignment for the benefit of creditors, and Eargo's notice says an assignee is "managing an orderly wind-down." The LXE notice, dated September 2, 2026, stopped new warranty or repair requests after September 15 and set the Lexie app's removal for October 8, 2026. The same notice says the aids "are expected to continue functioning" on local controls or the last saved profile.

Owners who are owed something can file a Proof of Claim by January 31, 2027, and the notice adds: "Filing a Proof of Claim does not guarantee payment." The dates and steps are on our Lexie and Eargo pages.

Go Hearing sits in the same picture. FDA device identifier records list the Go Ultra under the Go Hearing brand as an OTC device, with HEARX GROUP (PTY) LTD as labeler. hearX USA, Inc. is one of the companies in the July 15, 2026 assignment, so the January 31, 2027 Proof of Claim deadline applies to its creditors too. The notice asks you to file against "the specific legal entity responsible for the obligation." A device identifier record does not show whether a model is still sold or supported, so ask the seller who now honors the return before you buy.

Paying with an FSA, an HSA or Medicare

IRS Publication 502 counts the cost of a hearing aid, with the batteries, repairs and maintenance needed to operate it, as a medical expense. It makes no OTC exception. A health FSA reimburses qualified expenses specified in the plan, so read the plan, and HSA distributions used for qualified medical expenses are not taxed. Details are on FSA and HSA rules for hearing aids.

Original Medicare does not cover hearing aids. In 2026 CMS data, 2,103 of 5,599 Medicare Advantage plan segments (37.6%) file an OTC hearing aid benefit, and each plan's terms set what it pays: OTC hearing aids and Medicare.