MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO P90-312; HEARING AID; RECEIVER-IN-CANAL (RIC)

Model Number	0500769P8
Medical Device Problem Codes	Output Problem (3005); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Acoustic Shock (1693); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After the incident, the patient reported no issues with the hi functioning.Investigation and follow up aiming at determining circumstances of the incident, impact on the patient and the potential source of the issue have been initiated.Additional information will be provided upon availability.
Event or Problem Description
The patient experienced loud noise exposure, after which the patient heard a loud sound in the hearing aids and then all sound got really quiet.There are concerns over decreased hearing.The patient didn't report any other symptoms.
Event or Problem Description
The patient experienced loud noise exposure (hammer hitting metal), which caused the patient to hear a loud sound for a brief moment, but the sound was quickly muted by the his.The incident was initially reported due to concerns over patient's decreased hearing.However, it was clarified that the patient did not experience any clinical signs and symptoms and did not require medical intervention.Patient's hearing has not been impacted due to this event.
Additional Manufacturer Narrative
The follow up established that the patient heard a hammer hit metal and the loud sound was quickly muted by the his for a brief moment.Afterwards, the his worked again (amplified sound) as normal.This indicates that the control measures aimed at protecting the patient from too high sound exposure functioned as intended in the described situation.Patient did not experience pain or any other symptoms and did not require any medical intervention due to this event.The hearing test was performed after the incident and there was no change in patient's hearing observed.The patient is currently wearing the his without any issues.The manufacturer excludes adverse event and considers this incident as non-reportable.

• Brand Name: PHONAK AUDEO P90-312
• Common Device Name: HEARING AID; RECEIVER-IN-CANAL (RIC)
• Manufacturer (Section D): SONOVA AG; laubisrutistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrutistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 20479250
• Report Number: 3005085999-2024-00022
• Device Sequence Number: 20901884
• Product Code: OSM
• UDI-Device Identifier: 07613389352313
• UDI-Public: (01)07613389352313
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 10/04/2024

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: 0500769P8
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2021
• 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 P90-312 S/N: (B)(6), REF: (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female