MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO I90-R; HEARING AID, RECEIVER-IN-CANAL

Model Number	0501050P5
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Discomfort (2330); Partial Hearing Loss (4472)
Date of Event	12/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received an incoming call on his mobile phone, and it rang very loudly in his hearing aids, causing him to be startled and feel discomfort.Afterwards, he experienced that his hearing worsen in his right ear, which he associates with this situation.He experienced a loud streaming sound/notification sound in both hearing aids, but only the right ear has experienced reduced hearing afterwards.An audiogram taken on (b)(6) shows a clear change compared with measurements from on (b)(6).
Additional Manufacturer Narrative
The manufacturer received the complaint and initiated an investigation.Normally it is not expected that an exposure to sudden loud noise for a short duration will lead to a permanent threshold shift.The manufacturer requested more information and the devices for technical analysis.(4112) the information received so far from the hcp is that a 30 db reduced hearing was measured at 2khz.Only one frequency is reduced.Repeated audiogram confirmed this finding.The incident happened during christmas 2025 and the hearing test was performed on (b)(6) 2026.The patient had received streamed call notifications before and after this incident but did not experience any other loud sounds.The notification volume setting on the mobile phone is described as normal.The patient is still using these hearing aids.The hcp finds it hard to assess if this event caused further hearing loss but finds it probable.(4109) no other serious incidents due to loud sound/output issue were recorded by sonova since the device launch in august 2024.The manufacturer did not record any trends on the market for this or similar devices.(analysis of service/maintenance records, b32) this device was not serviced before.The investigation is ongoing and more information will be provided later.

• Brand Name: PHONAK AUDÉO I90-R
• Common Device Name: HEARING AID, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 24556421
• Report Number: 3005085999-2026-00004
• Device Sequence Number: 18350078
• Product Code: OSM
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0501050P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown