MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO I-SPHERE TRIAL; AIR-CONDUCTION HEARING AID, RECEIVER-IN-CANAL

Model Number	0501030P6
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	11/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer initiated a follow up, requested hearing aid fitting files and the device for analysis.The investigation is ongoing.Additional reports will be submitted upon availability.
Event or Problem Description
It was reported that the hearing aid significantly amplified joyfully said hello at a party and the patient suffered a sudden hearing loss.The patient went directly to the ent and was prescribed cortisol.
Additional Manufacturer Narrative
The hcp did not respond to the manufacturer despite six follow up attempts.The device, as well as, the fitting files have not been returned for the analysis and it is not possible to determine the exact root cause of this incident.However, a similar risk leading to aggravation of hearing loss has been already considered in the corresponding risk file and the risk file is considered adequate.The user guide contains information about the potential exposure to higher levels of sound and a warning regarding hearing deterioration/damage e.G.That a small group of hearing aid wearers with hearing loss may be at risk of deterioration in hearing after a long period of use.The manufacturer has not recorded any other similar (reportable or non-reportable) complaints for this device model so far.The manufacturer will observe for trends.This is the final report.

• Brand Name: PHONAK AUDEO I-SPHERE TRIAL
• Common Device Name: AIR-CONDUCTION 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: 20922443
• Report Number: 3005085999-2024-00029
• Device Sequence Number: 8391051
• Product Code: OSM
• UDI-Device Identifier: 07613389583038
• UDI-Public: (01)07613389583038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0501030P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHONAK AUDEO I-SPHERE TRIAL S/N: (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown