PHONAKRecalls & reported problems across all models
Sonova AG · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 13 models of PHONAK by Sonova AG in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2022 and Sep 23, 2026 — classified as 25 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PHONAK problems
Device problems
- Adverse Event Without Identified Device or Use Problem11
- Break4
- Detachment of Device or Device Component4
- Insufficient Device Problem Information4
- Output Problem3
- Overheating of Device3
- Battery Problem2
- No Apparent Adverse Event2
Patient problems
- Foreign Body In Patient4
- Infectious Otitis Externa3
- Itching Sensation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blister2
- Ear Pain2
- Ear infection2
- Partial Hearing Loss2
PHONAK models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PHONAK 078-0060Hearing aid, air conduction4 reports
- PHONAK 078-0062Hearing aid, air conduction4 reports
- PHONAK 078-0063Hearing aid, air conduction4 reports
- PHONAK 078-0061Hearing aid, air conduction3 reports
- PHONAK 050-0439-P5Hearing aid, air conduction with wireless technology2 reports
- PHONAK 078-0065Hearing aid, air conduction2 reports
- Phonak 063-0236-01Masker, tinnitus1 report
- Phonak 050-0476-M8Hearing aid, air conduction with wireless technology1 report
- PHONAK 050-0485-P3Masker, tinnitus1 report
- PHONAK 050-0491-P3Hearing aid, air conduction with wireless technology1 report
- Phonak 050-0675-P5Hearing aid, air conduction with wireless technology1 report
- Phonak 050-0676-P3Hearing aid, air conduction with wireless technology1 report
- Phonak 063-0500-01Hearing aid, air conduction with wireless technology1 report
Recent PHONAK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Overheating of Device; Battery Problem
Patient problems: Skin Burning Sensation
MAUDE report 50869313 ↗InjurySep 21, 2026Overheating of Device; Battery Problem
Sonova was notified that a hearing aid became hot while being worn by a user, resulting in a burning sensation to the back of the ear. The user removed the device due to the heat. Following the event, the device would not power on or charge and was reported as non-functional.
Patient problems: Skin Burning Sensation
MAUDE report 50840843 ↗InjuryJan 15, 2026Break; Detachment of Device or Device Component
SONOVA WAS NOTIFIED ABOUT AN INCIDENT IN WHICH HARING AID'S RECEIVER STUCK IN THE PATIENT'S EAR. PATIENT HAD TO GO TO THE EMERGENCY ROOM TO REMOVE THE RECEIVER FROM HER EAR. SHE IS NOW AFRAID TO WEAR HER HIS.
Patient problems: Foreign Body In Patient
MAUDE report 24077719 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT USING LYRIC HEARING AID EXPERIENCE EAR BLEEDING DURING DEVICE REMOVAL BY THE HCP.
Patient problems: Blister; Itching Sensation; Skin Tears
MAUDE report 22883624 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT USING LYRIC HEARING AID EXPERIENCE EAR BLEEDING DURING DEVICE REMOVAL BY THE HCP.
Patient problems: Blister; Itching Sensation; Skin Tears
MAUDE report 22663417 ↗InjuryJul 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE MANUFACTURER WAS NOTIFIED ABOUT A PATIENT SHOWING A STRONG REACTION IN THE AREA WHERE THE HEARING AID IS WORN WITH SCALY, REDDENED, ITCHY SKIN. THE PATIENT ONLY WEARS A HEARING AID MONAURALLY, THE REACTION IS PROBABLY DUE TO WEARING THE HEARING AID, AS THERE ARE NO SIGNS OF IT ON THE OTHER EAR. THE PATIENT HAS BEEN PRESCRIBED AN OINTMENT BY THE ENT.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation
MAUDE report 22641703 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT HAS NOTICED EXCESS FLUID COLLECTION AND WHITE, THICK DEBRIS IN THE EAR UPON REMOVAL OF THE DEVICE AND SOUGHT MEDICAL TREATMENT.
Patient problems: Infectious Otitis Externa
MAUDE report 22541763 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT HAS NOTICED EXCESS FLUID COLLECTION AND WHITE, THICK DEBRIS IN THE EAR UPON REMOVAL OF THE DEVICE AND SOUGHT MEDICAL TREATMENT.
Patient problems: Infectious Otitis Externa
MAUDE report 22478920 ↗InjuryJun 23, 2025Output Problem; Output Problem
THE HCP REPORTS THAT THE END USER HAS RECEIVED A POP TRAUMA DUE TO A FEEDBACK MEASUREMENT AFTER DELIVERY OF A NEW EARPIECE, WHICH HAS SIGNIFICANTLY INCREASED HIS ALREADY PREEXISTING TINNITUS AND HE CAN NO LONGER PARTICIPATE IN NORMAL LIFE.
Patient problems: Tinnitus
MAUDE report 22306712 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO THE MANUFACTURER THAT DARK GREEN FLUID WAS OBSERVED IN THE PATIENT'S EAR CANAL UPON LYRIC REMOVAL. THE DEVICE WAS IN USE FOR 53 DAYS AND WAS REMOVED DURING A SCHEDULED REMOVAL APPOINTMENT. THE HCP IS SUSPECTING AN INFECTION AND HAD REFERRED THE PATIENT TO THE ENT BEFORE THE PLACEMENT OF A NEW LYRIC DEVICE.
Patient problems: Ear infection; Fluid Discharge
MAUDE report 21933768 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DEVICE WAS IN USE FOR 59 DAYS. THE DEVICE WAS REMOVED FROM THE PATIENT'S EAR DURING A SCHEDULED REMOVAL APPOINTMENT. AFTER THE REMOVAL, THE ENT OBSERVED INFECTION IN THE PATIENT'S EAR. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO TREAT THE EAR.
Patient problems: Infectious Otitis Externa
MAUDE report 21355072 ↗InjuryFeb 11, 2025Output Problem; Output Problem
DEVICE WAS FIT ON (B)(6) 2025 AND WAS IN USE FOR 7 DAYS. DEVICE BECAME WEAK AND WAS REMOVED FROM THE PATIENT'S EAR. UPON REMOVAL EXCESS FLUID COLLECTION IN PATIENT'S EAR WAS OBSERVED. THE FLUID WAS WHITE AND SOMEHOW THICK. THE PATIENT WENT TO THE URGENT CARE TO EXAMINE THE EAR AND IS RECEIVING ANTIBIOTIC DROPS.
Patient problems: Ear infection
MAUDE report 21354790 ↗InjuryDec 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT HAS BEEN REPORTED THAT THE DEVICE GOT STUCK AND A FRONT PANEL CAME OFF DURING THE PROCEDURE OF SCHEDULED REMOVAL BY THE HCP. THE PATIENT WAS SENT TO ENT, WHO REMOVED THE DEVICE AND TREATED TRAUMA.
Patient problems: Foreign Body In Patient
MAUDE report 20922440 ↗InjuryDec 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT HAS BEEN REPORTED THAT ON THE HCP'S ATTEMPT TO REMOVE LYRIC FROM A PATIENT'S EAR, PART OF THE DEVICE TOTALLY SNAPPED OFF AND THE HCP WAS UNABLE TO REMOVE THE DEVICE FROM PATIENT'S EAR. THE PATIENT WAS SENT FOR AN URGENT PRIVATE ENT APPOINTMENT.
Patient problems: Foreign Body In Patient
MAUDE report 20840597 ↗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 Sonova AG products
All Sonova AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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