{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ballerup",
      "state": "",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83906",
      "recalling_firm": "GN Hearing A/S",
      "address_1": "Lautrupbjerg 7",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-0584-2020",
      "product_description": "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",
      "product_quantity": "285 units",
      "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.",
      "recall_initiation_date": "20190918",
      "center_classification_date": "20191127",
      "termination_date": "20230531",
      "report_date": "20191204",
      "code_info": "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",
      "more_code_info": ""
    }
  ]
}