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U.S. Department of Health and Human Services

Class 2 Device Recall IntheEar hearing aids

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  Class 2 Device Recall IntheEar hearing aids see related information
Date Initiated by Firm September 18, 2019
Create Date November 27, 2019
Recall Status1 Terminated 3 on May 31, 2023
Recall Number Z-0584-2020
Recall Event ID 83906
Product Classification Hearing aid, air conduction - Product Code ESD
Product 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
Code Information 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 1803133195 1903006692 1903057440 33. LT7ITE-DW-MP, Serial Numbers: 1803009437 1803009437 1803160540 1803160540 1903079661 1903081937 34. LT7ITE-DW-UP, Serial Numbers: 1703113348, 1703113348, 1803072886 35. LT7ITE-W-UP, Serial Numbers: 1903075215 36. LT7MIH-W-HP, Serial Numbers: 1703174838, 1703174839 37. LT7MIH-W-LP, Serial Numbers: 1703145770, 1903063156, 1903063157 38. LT7MIH-W-MP, Serial Numbers: 1803023734 1803023734 1903075536 1903075536 1903075536 39. LT9CIC-HP, Serial Numbers: 1803075237 40. LT9CIC-MP, Serial Numbers: 1803029934, 1803029935 41. LT9CIC-W-MP, Serial Numbers: 1903041934, 1903087552, 1903087553 42. LT9IIC-LP, Serial Numbers: 1703077904 1703101519 1703101519 1703163192 1803156219 1903069714 1903069715 1903074923 43. LT9ITC-DW-HP, Serial Numbers: 1803037070 1803118635 1803123719 1903081822 1903081822 1903081823 44. LT9ITC-DW-LP, Serial Numbers: 1803063234, 1803063235, 1903057161 45. LT9ITC-DW-MP, Serial Numbers: 1703164310 1703164310 1703193794 1803038532 1803038533 1803095725 1803120267 1803129376 1803148462 1803149711 1903063363 1903064701 1903069848 1903069849 1903070872 1903080626 46. LT9ITE-DW-HP, Serial Numbers: 1703180042 1703180042 1703187399 1703195449 1803036680 1803040508 1803102283 1803102283 1803110566 1803110566 1803112738 1803119128 1803163557 1803172840 1803172840 1903012660 1903012661 1903027832 1903027832 1903027833 1903030917 1903054755 1903055148 1903067092 1903067092 47. LT9ITE-DW-MP, Serial Numbers:  1703187734 1703187735 1803042986 1803048804 1803059824 1803098325 1803098325 1803112012 1803136679 1803150885 1803150885 1803152358 1803154771 1803172627 1803172627 1903007247 1903007247 1903019755 1903019755 1903021531 1903024789 1903032503 1903036839 1903044106 1903044107 1903049105 1903051725 1903054724 1903057935 1903057935 1903063614 1903063615 1903064883 1903085695 48. LT9ITE-DW-UP, Serial Numbers: 1803003623 1903009154 1903058802 1903061212 1903061213 49. LT9MIH-HP, Serial Numbers: 1703193879 50. LT9MIH-MP, Serial Numbers: 1703156670, 1803075250 51. LT9MIH-W-HP, Serial Numbers: 1803036959 1803036959 1803056771 1803131205 52. LT9MIH-W-LP, Serial Numbers: 1803154516, 1803154517, 1903067101 53. LT9MIH-W-MP, Serial Numbers: 1703095504 1803002082 1803002083 1803004586 1803004587 1803005154 1803005154 1803010361 1803015696 1803027022 1803065264 1803101274 1803108974 1803108975 1903083931 1903083931 54. TST17IIC-LP, Serial Numbers: 1803075936, 1803075937, 1803075937 55. TST17ITC-DW-HP, Serial Numbers: 1703176061 56. TST17ITE-HP, Serial Numbers: 1703172380 57. TST17MIH-W-UP, Serial Numbers: 1903045044 58. TST6CIC-HP, Serial Numbers: 1803152854, 1803152855 59. TST6IIC-LP, Serial Numbers: 1903085966 60. TST6ITC-MP, Serial Numbers: 1803148112 61. TST6ITC-W-HP, Serial Numbers: 1903076502 1903076502 1903076503 1903076503 1903076503 62. TST6ITC-W-MP, Serial Numbers: 1803122409 63. TST6ITE-DW-UP, Serial Numbers: 1903073776 64. TST6ITE-HP, Serial Numbers: 1803175636, 1803175637 65. TST6ITE-W-UP, Serial Numbers: 1903035501 66. TST6MIH-W-HP, Serial Numbers: 1803131659 67. TST9ITC-DW-MP, Serial Numbers: 1803085859 68. TST9ITE-DW-HP, Serial Numbers: 1903021719, 1903040718 69. TST9ITE-MP, Serial Numbers: 1703156356 70. TST9MIH-W-MP, Serial Numbers: 1803146106, 1803146107 71. VA8CIC-HP, Serial Numbers: 1903052943, 1903065362, 1903065363 72. VA8CIC-MP, Serial Numbers: 1903014109 73. VA8IIC-LP, Serial Numbers: 1903076780 74. VA8ITC-DW-HP, Serial Numbers: 1903017808, 1903017808 75. VA8ITC-DW-MP, Serial Numbers: 1903012095 1903054236 1903084520 1903084521 76. VA8ITC-W-MP, Serial Numbers: 1903089414, 1903089415 77. VA8ITE-D-HP, Serial Numbers: 1803152758 78. VA8ITE-DW-HP, Serial Numbers: 1803172901 1803172901 1903061516 1903061517 1903084429 79. VA8ITE-DW-UP, Serial Numbers: 1903017250 80. VA8MIH-W-MP, Serial Numbers: 1903030580, 1903047228 
Recalling Firm/
Manufacturer		 GN Hearing A/S
Lautrupbjerg 7
Ballerup Denmark
For Additional Information Contact Rich Fischer
800-248-4327 Ext. 8461
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Other
Action The firm initiated the recall by telephone on 09/18/2019 and followed with a letter customized to each consignee. The requests the return of the affected units. The letter also requests that any entity that distributed the product notify their customers.
Quantity in Commerce 285 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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