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Phonak 050-0476-M8Recalls & reported problems

Sonova AG · Phonak Sky B70-UP (majesty purple) · Class 2

All models of PHONAK (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613275609798), received between Oct 1, 2024 and Oct 1, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Communication or Transmission Problem1
  • Output Problem1

Patient problems

  • Acoustic Trauma1
  • Ambulation or Postural Difficulties1
  • Anxiety1
  • Brain Injury1
  • Depression1
  • Dizziness1
  • Ear Pain1
  • Nausea1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 1, 2024Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

    SONOVA HAS RECEIVED A CLAIM THAT THE FOLLOWING EVENT HAS HAPPENED IN 2022: AFTER PASSING THROUGH THE AREA OF THE ANTI THEFT ALARM SYSTEM IN A SHOPPING STORE, THE PATIENT (ADULT) EXPERIENCED IMMEDIATE AND EXTEREME PAIN IN HER HEAD AND EARS AND A SHOCK DOWN ONE OF HER LEGS. THE HEARING AIDS WERE DAMAGED AND DUE TO THIS THE PATIENT SUFFERED A LOSS OF HEARING, CONFUSION AND DISORIENTATION. UPON EXITING THE STORE THROUGH ANOTHER ANTI THEFT ALARM SYSTEM, THE PATIENT EXPERIENCED THE SAME ISSUES AGAIN AND SUFFERED FURTHER INTENSE HEAD AND EAR PAIN AND OTHER INJURIES.

    Patient problems: Acoustic Trauma; Ambulation or Postural Difficulties; Anxiety; Brain Injury; Depression; Dizziness; Ear Pain; Nausea; Partial Hearing Loss; Tinnitus; Vertigo

    MAUDE report 20345507 ↗

Other Hearing aid, air conduction with wireless technology devices

All Hearing aid, air conduction with wireless technology devices →

Sources and updates

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