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Audien Hearing Aids: Amplifier or Hearing Aid? Prices and FDA Records

FDA's device database files the Audien Atom ONE and ION Pro 2 as over-the-counter hearing aids, under codes QUF and QUG; the ION 2 has no entry under that name. In October 2026, Audien listed the Atom ONE at $98 a pair, the ION 2 from $489 and the ION Pro 2 at $689.

Cost and coverage research team

Figure 1

Audien names in FDA records

Audien names in FDA records
Atom ONE 2 GUDID entries QUF Over-the-counter air-conduction hearing aid Class 1 Marked exempt Budget Hearing Aids, LLC
ION 2 No GUDID entry under this name; ion2 on one factory listing QUF on the listing Over-the-counter air-conduction hearing aid Class 1 on the listing Not established Austar Hearing Science & Technology, by name match only
ION Pro 2 2 GUDID entries QUG Over-the-counter air-conduction hearing aid with wireless technology Class 2 Marked exempt Budget Hearing Aids, LLC; Xiamen Vienatone Medical Technology
Atom, Atom Pro, Atom 2, Atom Pro 2, Audien ion, Audien BTE 6 GUDID entries QUF Over-the-counter air-conduction hearing aid Class 1 Marked exempt Budget Hearing Aids, LLC
Atom X, ion pro 3 GUDID entries QUG Over-the-counter air-conduction hearing aid with wireless technology Class 2 Marked exempt Budget Hearing Aids, LLC; Xiamen Vienatone on one ion Pro entry
Atom Air, Ion IQ, Ion Air No GUDID entry under these names Atom Air QUF and Ion IQ QUG on factory listings; Ion Air none found Not established for Ion Air Not established for Ion Air Not established By name match only
How to read these numbers (1)
  • Read on October 30, 2026 from exact-name openFDA searches. A name match on a factory listing leaves open whether the listed device is the Audien product, and a blank can mean a filing under another name.
Source:

Is an Audien an amplifier or a hearing aid?

FDA's files put Audien devices in the hearing aid category. All 13 entries under the brand name Audien Hearing in GUDID, FDA's device identifier database, carry a hearing aid code: 8 have QUF, an over-the-counter air-conduction hearing aid, and 5 have QUG, the same type with wireless technology.

The word amplifier alone can't separate the two ideas. Federal rules define both types as a "wearable sound-amplifying device" intended to compensate for impaired hearing, in 21 CFR 874.3300 and 21 CFR 874.3305. A code records the category a device was filed under. How finely a model shapes sound is a separate question, one these files leave open.

The ION 2 is the gap in the table. GUDID holds no entry under that name. The name ion2 turns up on a QUF listing held by Austar Hearing Science & Technology in Xiamen, China, and that listing doesn't mention Audien. GUDID does hold an Audien ion entry, but nothing in it says whether it covers the ION 2, so ask Audien which entry applies.

Three other names on Audien's Shop menu have no GUDID entry under the brand either. Atom Air appears on Austar's QUF listing and Ion IQ on the QUG listings of both Xiamen Vienatone and Austar, while a listing search for Ion Air returned no match.

What "FDA Registered" on Audien's site covers

Audien's product page carried an FDA Registered badge when we read it in October 2026. Registration is a separate thing from approval: under 21 CFR 807.39, assignment of a registration number "does not in any way denote approval" of an establishment or its products.

Premarket status. All 13 GUDID entries are marked exempt from premarket review, and both rules exempt their hearing aid type from premarket notification, within stated limits. A 510(k) is a premarket submission to FDA, and searches for one with Audien, Budget Hearing and Vienatone as applicant, and Audien and Atom ONE as device name, returned no match. These files show exempt entries, with no 510(k) clearance attached.

Whose registration? Establishment and owner-operator searches on Audien and on Budget Hearing returned no match on October 30, 2026. The registration numbers we found belong to factories whose listings use the same model names: Xiamen Vienatone, 3030396448; Austar, 3008606477; Xiamen Retone, 3010408889. What we read doesn't say which registration the badge means, and a no-match can reflect a filing under another name. Audien can tell you the number behind its badge.

Whose name is on Audien's FDA records

The company field in GUDID reads Budget Hearing Aids, LLC on 11 of the 13 Audien Hearing entries and Xiamen Vienatone Medical Technology on the other 2, ion Pro and ion Pro 2. Searching GUDID with Audien as the company returned no match. Reports sent to FDA draw the same link, with a manufacturer field reading "AUDIEN HEARING / BUDGET HEARING AIDS LLC."

Factory listings add a second layer, and here the tie is weaker. Austar's listing covers ATOM ONE, ATOM 2, ATOM PRO2 and Atom Air, and Xiamen Retone's covers Atom, Atom Pro, Atom 2, Atom pro2 and Atom One. FDA's files type both as medical device manufacturers and as contract manufacturers. Neither listing says Audien, so each match rests on a model name, and names collide: Guangdong ENNO Medical Technology also lists an ion pro.

Vienatone is the firmest factory tie, since GUDID places its name on entries branded Audien Hearing. None of these records says where a given pair was built.

What Audien hearing aids cost, and where Audien says they sell

In October 2026, Audien listed the Atom ONE at $98, the ION 2 from $489 and the ION Pro 2 at $689, each per pair, on the pages linked in the sources below. The Atom ONE box is described as 1 pair of aids, so that entry figure buys a pair rather than a single aid. Prices elsewhere were outside this reading, so confirm the figure at the seller you choose.

The Atom ONE sits under QUF and the ION Pro 2 under QUG, the wireless code, so the two differ in FDA category as well as in price. Audien's Shop menu, read the same month, shows the Atom Air, Atom X (2nd Gen), Ion Pro 2, Ion IQ and Ion Air.

Audien's site footer names Walgreens, Target, Walmart, Costco, CVS, BJ's, Staples and Giant Eagle. Stock and shelf prices need checking with each store, and free trial hearing aids sets out trial rights by state.

Audien complaints and recalls in FDA records

Recalls: no match. FDA's recall and enforcement data returned nothing on October 30, 2026 for Audien as a product or firm, or for Budget Hearing as a firm.

Reports: 28 numbers, fewer cases. MAUDE, FDA's adverse event database, last updated October 13, 2026, returned 28 report numbers across searches on the Audien and Budget Hearing names, all marked voluntary. They arrived on 13 dates. Of those reports, 22 fall on 7 dates where the filings largely repeat one account, so the raw count overstates separate cases.

Coded problems include charging failures (6 reports on 2 dates), overheating (1) and electromagnetic interference (2). The two interference reports, MW6002909 and MW6002910, name refurbished Ion Pro 2 and Ion Pro units. No report names the Atom ONE; one report (MW5175183) names "Audien ION hearing aids" without a generation, and 11 carry only a generic name.

These counts can't become a failure rate. openFDA notes a lack of information about frequency of device use, and the accounts come from voluntary reporters and remain unverified.

Frequently asked questions

Does Walmart sell Audien hearing aids?

Audien's site footer named Walmart among its retailers when we read it in October 2026. We did not read Walmart's own listings, so look up the model and your store on Walmart's site before you go.

Does Medicare cover hearing aids for seniors?

Original Medicare doesn't cover hearing aids or the exams for fitting them, so you pay all costs, as the Medicare hearing aid coverage page explains. Some Medicare Advantage plans offer hearing benefits, covered on Medicare Advantage hearing aid coverage.

Sources

FDA details come from exact-name openFDA searches archived with their date, with reports de-duplicated by report number. Audien's prices and site elements were read by hand on its own pages and cited with the month of reading; prices stay out of the table.

  1. https://audienhearing.com/products/audien-atom-one-hearing-aid
  2. https://audienhearing.com/products/audien-ion-otc-hearing-aids-new
  3. https://api.fda.gov/device/udi.json?search=brand_name%3A%22Audien%22&limit=100
  4. https://api.fda.gov/device/udi.json?search=company_name%3A%22Audien%22&limit=100
  5. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22ion2%22&limit=100
  6. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22Ion+IQ%22&limit=100
  7. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22Atom+ONE%22&limit=100
  8. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22ION+Pro%22&limit=100
  9. https://api.fda.gov/device/registrationlisting.json?search=registration.name%3A%22Audien%22&limit=100
  10. https://api.fda.gov/device/registrationlisting.json?search=registration.owner_operator.firm_name%3A%22Audien%22&limit=100
  11. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22Audien%22&limit=100
  12. https://api.fda.gov/device/registrationlisting.json?search=registration.name%3A%22Budget+Hearing%22&limit=100
  13. https://api.fda.gov/device/registrationlisting.json?search=registration.owner_operator.firm_name%3A%22Budget+Hearing%22&limit=100
  14. https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22Ion+Air%22&limit=100
  15. https://api.fda.gov/device/510k.json?search=applicant%3A%22Audien%22&limit=100
  16. https://api.fda.gov/device/510k.json?search=device_name%3A%22Audien%22&limit=100
  17. https://api.fda.gov/device/510k.json?search=applicant%3A%22Budget+Hearing%22&limit=100
  18. https://api.fda.gov/device/510k.json?search=applicant%3A%22Vienatone%22&limit=100
  19. https://api.fda.gov/device/510k.json?search=device_name%3A%22Atom+ONE%22&limit=100
  20. https://api.fda.gov/device/recall.json?search=product_description%3A%22Audien%22&limit=50
  21. https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Audien%22&limit=50
  22. https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Budget+Hearing%22&limit=50
  23. https://api.fda.gov/device/enforcement.json?search=product_description%3A%22Audien%22&limit=50
  24. https://api.fda.gov/device/enforcement.json?search=recalling_firm%3A%22Audien%22&limit=50
  25. https://api.fda.gov/device/enforcement.json?search=recalling_firm%3A%22Budget+Hearing%22&limit=50
  26. https://api.fda.gov/device/event.json?search=device.manufacturer_d_name%3A%22Audien%22&limit=100
  27. https://api.fda.gov/device/event.json?search=mdr_text.text%3A%22Audien%22&limit=100
  28. https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec874-3300.pdf
  29. https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec874-3305.pdf
  30. https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec807-39.pdf
  31. https://open.fda.gov/apis/device/510k/
  32. https://open.fda.gov/apis/device/event/
  33. https://www.medicare.gov/coverage/hearing-aids

Cost and coverage research team Methodology

Cost and coverage research, not medical advice. FDA records describe filings and reports rather than how an aid will work for you; a hearing care professional can advise on your hearing.