STARKEY STARKEY EVOLV AI 1200 RIC RRecalls & reported problems
Starkey Laboratories, Inc. · Class 2
Data updated Oct 18, 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 00842318185037), received between Sep 28, 2022 and Sep 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Electromagnetic Compatibility 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 18, 2026.
Most reported problems
Device problems
- Electromagnetic Compatibility Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2022Electromagnetic Compatibility Problem; Unexpected Shutdown
MY HEARING AID TURNED OFF AFTER PASSING THROUGH AN ANTI-THEFT GATE AT A DRUG STORE. I COULD NOT TURN THE HEARING AID BACK ON FOR 20 MINUTES. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15503286 ↗
Other Masker, tinnitus devices
- Phonak 063-0236-01Sonova AG · Masker, tinnitus1 report
- PHONAK 050-0485-P3Sonova AG · Masker, tinnitus1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page