Phonak Audéo I90-Sphere (graphite gray)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613389686630), received between Oct 15, 2025 and Nov 21, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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, 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT IS REPORTING HE HAS HAD 7 EAR INFECTIONS SINCE BEING FITTED WITH CURRENT CSHELLS WITH HIS AUDIO I90-SPHERE DEVICES. THE PATIENT IS A LONG-TIME HEARING AID WEARER AND NEVER HAD EAR INFECTIONS BEFORE WEARING THE CURRENT CSHELLS. HE WAS SEEN BY BOTH HIS PRIMARY CARE PHYSICIAN (PCP) AND AN ENT. THE DOCTOR SAID HE BELIEVES THE CSHELLS ARE CAUSING THE INFECTIONS. THE HCP DID NOT REMEMBER IF THE PCP OR ENT SAID THIS. THE PATIENT HAS BEEN PRESCRIBED MULTIPLE ROUNDS OF ANTIBIOTICS TO TREAT THE EAR INFECTIONS. THIS CASE CONCERNS ONE PATIENT BOTH EARS = 2 CSHELLS (SNS: (B)(6) WORN WITH AUDIO I90-SPHERE HIS (SNS: (B)(6).

  Patient problems: Ear infection

  MAUDE report 23624795 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT IS REPORTING HE HAS HAD 7 EAR INFECTIONS SINCE BEING FITTED WITH CURRENT CSHELLS WITH HIS AUDEO I90-SPHERE DEVICES. THE PATIENT IS A LONG-TIME HEARING AID WEARER AND NEVER HAD EAR INFECTIONS BEFORE WEARING THE CURRENT CSHELLS. HE WAS SEEN BY BOTH HIS PRIMARY CARE PHYSICIAN (PCP) AND AN ENT. THE DOCTOR SAID HE BELIEVES THE CSHELLS ARE CAUSING THE INFECTIONS. THE HCP DID NOT REMEMBER IF THE PCP OR ENT SAID THIS. THE PATIENT HAS BEEN PRESCRIBED MULTIPLE ROUNDS OF ANTIBIOTICS TO TREAT THE EAR INFECTIONS. THIS CASE CONCERNS ONE PATIENT BOTH EARS = 2 CSHELLS (SNS: (B)(6)) WORN WITH AUDEO I90-SPHERE HIS (SNS: (B)(6)).

  Patient problems: Ear infection

  MAUDE report 23623562 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT IS REPORTING HE HAS HAD 7 EAR INFECTIONS SINCE BEING FITTED WITH CURRENT CSHELLS WITH HIS AUDEO I90-SPHERE DEVICES. THE PATIENT IS A LONG-TIME HEARING AID WEARER AND NEVER HAD EAR INFECTIONS BEFORE WEARING THE CURRENT CSHELLS. HE WAS SEEN BY BOTH HIS PRIMARY CARE PHYSICIAN (PCP) AND AN ENT. THE DOCTOR SAID HE BELIEVES THE CSHELLS ARE CAUSING THE INFECTIONS. THE HCP DID NOT REMEMBER IF THE PCP OR ENT SAID THIS. THE PATIENT HAS BEEN PRESCRIBED MULTIPLE ROUNDS OF ANTIBIOTICS TO TREAT THE EAR INFECTIONS. THIS CASE CONCERNS ONE PATIENT BOTH EARS = 2 CSHELLS (SNS: (B)(6) WORN WITH AUDEO I90-SPHERE HIS (SNS: (B)(6). THIS CASE IS LINKED TO 3005085999-2025-00038.

  Patient problems: Ear infection

  MAUDE report 23615813 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT IS REPORTING HE HAS HAD 7 EAR INFECTIONS SINCE BEING FITTED WITH CURRENT CSHELLS WITH HIS AUDEO I90-SPHERE DEVICES. THE PATIENT IS A LONG-TIME HEARING AID WEARER AND NEVER HAD EAR INFECTIONS BEFORE WEARING THE CURRENT CSHELLS. HE WAS SEEN BY BOTH HIS PRIMARY CARE PHYSICIAN (PCP) AND AN ENT. THE DOCTOR SAID HE BELIEVES THE CSHELLS ARE CAUSING THE INFECTIONS. THE HCP DID NOT REMEMBER IF THE PCP OR ENT SAID THIS. THE PATIENT HAS BEEN PRESCRIBED MULTIPLE ROUNDS OF ANTIBIOTICS TO TREAT THE EAR INFECTIONS. THIS CASE CONCERNS ONE PATIENT BOTH EARS = 2 CSHELLS (SNS: (B)(6) WORN WITH AUDEO I90-SPHERE HIS (SNS: (B)(6). THIS CASE IS LINKED TO 3005085999-2025-00039.

  Patient problems: Ear infection

  MAUDE report 23615655 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT THE PATIENT IS REPORTING RECURRENT OTITIS EXTERNA WHILE USING A CSHELL 6.0 WITH HIS HI (AUEDO I90-SPHERE). HE USES A CSHELL ON HIS LEFT EAR AND A DOME ON THE OTHER SIDE. HE PREVIOUSLY USED DOMES WITH HIS HEARING AIDS AND DID NOT HAVE AN ISSUE. THE PATIENT REPORTS "EVERY 6 WEEKS HE GETS ANOTHER (OUTER) EAR INFECTION" AND THIS BEGAN WHEN HE STARTED USING THE CSHELL (B)(6) 2024. THE PROVIDER HYPOTHESIZES THIS MAY BECAUSE IT FITS DEEPER THAN THE DOMES HE WAS USING. SYMPTOMS THE PATIENT HAS BEEN EXPERIENCING ARE "WHITE, SQUAMOUS DEBRIS" AS OBSERVED WITH OTOSCOPY AND HE HAS EXPERIENCED ITCHING. THE PATIENT HAS BEEN SEEING HIS PRIMARY PHYSICIAN TO HAVE EAR "FLUSHED OUT" AND HAS SEEN ENT "FOR TREATMENT". THE ENT HAS BEEN PRESCRIBING "ANTIBIOTIC DROPS" FOR TREATMENT. THIS HAS ALSO LED THE PATIENT LEAVING THE HEARING AID OUT FOR PERIODS OF TIME WHILE THE CONDITION RESOLVES.

  Patient problems: Ear infection

  MAUDE report 23304352 ↗