Amara View Amara View Mask with Headgear, SmallRecalls & reported problems
Respironics, Inc. · Amara View Mask with Headgear, Small · 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 00606959009134), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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
- Patient Device Interaction Problem1
Patient problems
- Partial Hearing Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN END USER WITH EAR IMPLANTS EXPERIENCED HEARING LOSS WHILE USING THE AMARA VIEW FACE MASK WITH MAGNETIC CLIPS. THE USER ALLEGEDLY USED THE MASK FOR TWO YEARS AND NOTICED A DECLINE IN HIS HEARING. THE CARE FACILITY FOR PATIENT CARE HAS CHANGED THE MASK TO ONE WITHOUT MAGNETS. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.
Patient problems: Partial Hearing Loss
MAUDE report 15835518 ↗
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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.
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