In-the-Ear hearing aids
Medical device recall Z-0584-2020. 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
- 285 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?
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-UP, LT7CIC-HP, LT7CIC-LP, LT7CIC-MP, LT7CIC-W-MP, LT7IIC-LP, LT7ITC-DW-LP, LT7ITC-DW-MP, LT7ITC-MP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITE-DW-HP, LT7ITE-DW-MP, LT7ITE-DW-UP, LT7ITE-W-UP, LT7MIH-W-HP, LT7MIH-W-LP, LT7MIH-W-MP, LT9CIC-HP, LT9CIC-MP, LT9CIC-W-MP, LT9IIC-LP, LT9ITC-DW-HP, LT9ITC-DW-LP, LT9ITC-DW-MP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-DW-UP, LT9MIH-HP, LT9MIH-MP, LT9MIH-W-HP, LT9MIH-W-LP, LT9MIH-W-MP, TST17IIC-LP, TST17ITC-DW-HP, TST17ITE-HP, TST17MIH-W-UP, TST6CIC-HP, TST6IIC-LP, TST6ITC-MP, TST6ITC-W-HP, TST6ITC-W-MP, TST6ITE-DW-UP, TST6ITE-HP, TST6ITE-W-UP, TST6MIH-W-HP, TST9ITC-DW-MP, TST9ITE-DW-HP, TST9ITE-MP, TST9MIH-W-MP, VA8CIC-HP, VA8CIC-MP, VA8IIC-LP, VA8ITC-DW-HP, VA8ITC-DW-MP, VA8ITC-W-MP, VA8ITE-D-HP, VA8ITE-DW-HP, VA8ITE-DW-UP, VA8MIH-W-MP
285 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
ITE Model Numbers 1. T9ITC-DW-LP, Serial Numbers: 1803042525 2. FT6ITC-D-MP, Serial Numbers: 1703186476 3. FT6ITE-D-MP, Serial Numbers: 1803046347 4. FT8CIC-MP, Serial Numbers: 1903001780 5. FT8ITC-W-HP, Serial Numbers: 1703204072 6.…
Every code shown here, 1,995 characters
ITE Model Numbers 1. T9ITC-DW-LP, Serial Numbers: 1803042525 2. FT6ITC-D-MP, Serial Numbers: 1703186476 3. FT6ITE-D-MP, Serial Numbers: 1803046347 4. FT8CIC-MP, Serial Numbers: 1903001780 5. FT8ITC-W-HP, Serial Numbers: 1703204072 6. FT8ITC-W-LP, Serial Numbers: 1803082537 7. FT8ITC-W-MP, Serial Numbers: 1803001903, 1803162395 8. FT8ITE-DW-HP, Serial Numbers: 1803007441 9. FT8MIH-W-HP, Serial Numbers: 1803099905, 1803105154 10. FT8MIH-W-MP, Serial Numbers: 1703187560 1803010468 1803010468 1803050131 1803088032 1803088032 1803088033 1803110197 11. LT5CIC-MP, Serial Numbers: 1703112759 1703112759 1803128423 1903035093 1903035093 1903035093 1903035093 12. LT5CIC-UP, Serial Numbers: 1903067660 13. LT5IIC-LP, Serial Numbers: 1903080274, 1903080275 14. LT5ITC-DW-MP, Serial Numbers: 1703127304 1703130569 1903042498 1903071182 15. LT5ITC-DW-UP, Serial Numbers: 1703170623, 1703170623 16. LT5ITE-DW-HP, Serial Numbers: 1703177839, 1703177839, 1703192785 17. LT5ITE-DW-MP, Serial Numbers: 1703115716 1703115716 1703116332 1703132690 1803138757 1903070073 18. LT5ITE-DW-UP, Serial Numbers: 1803150744, 1803150744 19. LT5MIH-W-HP, Serial Numbers: 1803128733 1903077880 1903077881 1903086704 20. LT5MIH-W-MP, Serial Numbers: 1803049552, 1803049553, 1903064066 21. LT5MIH-W-UP, Serial Numbers: 1803147577 22. LT7CIC-HP, Serial Numbers: 1903067586 23. LT7CIC-LP, Serial Numbers: 1803108278 24. LT7CIC-MP, Serial Numbers: 1703139899 1903001229 1903080678 1903080678 1903080679 25. LT7CIC-W-MP, Serial Numbers: 1903069574 1903069574 1903069574 1903069575 1903069575 26. LT7IIC-LP, Serial Numbers: 1803135688, 1803172396, 1803172397 27. LT7ITC-DW-LP, Serial Numbers: 1703131157, 1703131157 28. LT7ITC-DW-MP, Serial Numbers: 1703137227 1803006683 1903016654 1903016654 1903016655 29. LT7ITC-MP, Serial Numbers: 1703157616, 1703157616 30. LT7ITC-W-HP, Serial Numbers: 1803173827, 1903081129 31. LT7ITC-W-MP, Serial Numbers: 1903077370, 1903077371 32. LT7ITE-DW-HP, Serial Numbers: 1803005911 1803097637…
FDA’s list runs to 5,820 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 5,820 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.