Behind-the-Ear hearing aids
Medical device recall Z-0583-2020. Published in FDA’s Enforcement Report on Dec 4, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 4, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 590 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW
590 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
BTE Model Numbers 1. Q962-DRW, Serial Numbers: 1956267136 2. T561-DRW, Serial Numbers: 1826333136 3. T562-DRW, Serial Numbers: 1926268020 1926268023 4. T762-DRW, Serial Numbers: 1786530800 1786530800 1786530800 1786530800 5. T777-DW,…
Every code shown here, 1,991 characters
BTE Model Numbers 1. Q962-DRW, Serial Numbers: 1956267136 2. T561-DRW, Serial Numbers: 1826333136 3. T562-DRW, Serial Numbers: 1926268020 1926268023 4. T762-DRW, Serial Numbers: 1786530800 1786530800 1786530800 1786530800 5. T777-DW, Serial Numbers: 1856523922 6. AMZ964-DRW, Serial Numbers: 1886309928 1886309928 7. ET588-DWH, Serial Numbers: 1826694045 1886574434 1926917354 8. ET598-DW, Serial Numbers: 1826548362 1826548363 1826558523 1826558524 1886035343 1956138156 1956674808 1956674811 9. ET788-DWH, Serial Numbers: 1786681686 1949058624 10. ET798-DW, Serial Numbers: 1786671213 1826213864 1866083875 11. ET988-DWH, Serial Numbers: 1786702037 1826417609 1826605822 1886295047 1926360970 12. ET998-DW, Serial Numbers: 1826235478 1826558443 1826758611 1826863215 1826922716 1849162491 1866019090 1886543814 1926084437 13. FT861-DRW, Serial Numbers: 1786441534 1786441535 1786513836 1786575879 1826005162 1826072467 1826078212 1826319832 1826319844 1826384415 1826394747 1826412910 1826426853 1826428482 1826428482 1826428868 1826520235 1826521329 1826521330 1826665435 1826698784 1826752556 1826752557 1826827107 1826827165 1826827166 1826877557 1826886356 1826886357 1826926052 1826958345 1826958346 1826982966 1849076807 1849098981 1849103936 1886024051 1886075478 1886090034 1886288630 1886288631 1886422772 1949110545 1949178118 1949194578 1949194578 1949244608 14. FT862-DRW, Serial Numbers: 1826002195 1826108576 1826147261 1826206052 1826206056 1826266399 1826331700 1826349318 1826418888 1826663906 1826663907 1826902422 1826902453 1826935603 1826954235 1886387429 1886387430 1926019399 1926173465 1949006883 1950535217 15. RE561-DRWC, Serial Numbers: 1956481867 16. RE762-DRW, Serial Numbers: 1950393987 17. RE961-DRWC, Serial Numbers: 1886200466 1926008396 18. RE962-DRW, Serial Numbers: 1886355785 1886441408 1886469138 1886469160 1886469160 1886469161 1926059398 1926138562 1926138562 1926293595 1926312455 1926312455 1926312458 1926312458 1926379189 1926379190 1926524934…
FDA’s list runs to 7,799 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 18, 2019.
- FDA classified it on Nov 27, 2019.
- FDA’s Enforcement Report published it on Dec 4, 2019.
- FDA terminated it on May 31, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GN Hearing A/S, of Ballerup, Denmark.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,799 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.