eXciteOSA 801600001Recalls & reported problems
Signifier Medical Technologies Limited · eXciteOSA mouthpiece. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060627480017), received between Mar 11, 2022 and Mar 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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
- Device Markings/Labelling Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2022Device Markings/Labelling Problem
WITHOUT NOTIFYING PATIENTS SIGNIFIER MEDICAL CHANGED ITS SOFTWARE SO THAT THE MOUTHPIECE REQUIRED FOR OBSTRUCTIVE SLEEP APNEA (OSA) THERAPY EXPIRES AT THE END OF 90 DAYS. EACH NEW MOUTHPIECE PURCHASED NOW EXPIRES 90 AFTER FIRST USE. WITH THE OSA TREATMENT DEVICE. SIGNIFIER MEDICAL REPLIED TO ME VIA EMAIL THAT FDA MANDATED THEM TO MAKE THE DEVICE EXPIRE AT THE END OF 90 DAYS. UNTIL MADE TO EXPIRE, I USED MY INITIAL MOUTHPIECE SUPPLIED WITH THE DEVICE SAFELY FOR APPROXIMATELY 11 MONTHS. I DID NOT SUFFER ILL EFFECTS AND THE DEVICE WORKED THE SAME AS WHEN NEW, I DON'T BELIEVE THE FDA MANDATED EXPIRATION OF THE MOUTHPIECE AFTER 90 DAYS. THIS WAS DONE SOLELY TO SELL ADDITIONAL MOUTHPIECES IN ORDER TO MAKE MORE MONEY. THE SIGNIFIER MEDICAL EXCITE OSA DEVICE WAS APPROVED BY THE FDA. IT IS NOT HOWEVER, COVERED UNDER MEDICARE OR INSURANCE COMPANIES AT PRESENT. HAVING TO BUY A NEW MOUTHPIECE EVERY 90 DAYS WILL BE A FINANCIAL BURDEN ON MANY USERS. WHAT I WOULD LIKE FOR THE FDA TO DO IS REPLY WITH WHETHER OR NOT THERE IS A REQUIREMENT BY THE FDA TO MAKE THE MOUTHPIECE EXPIRE AT THE END OF 90 DAYS. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Insufficient Information
MAUDE report 13757448 ↗
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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