MAUDE Adverse Event Report: SONOVA AG PHONAK BOLERO M70-PR; HEARING AIDS, BEHIND-THE EAR

Model Number	0500676P3
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Tinnitus (2103)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer initiated an investigation.The initial follow up with the hcp established that the patient is still wearing the device and did not visit the clinic again, therefore the device cannot be sent for an analysis.The hcp fitted the patient with a new earpiece and wanted to carry out the feedback test, which is a part of a standard procedure, but the sound was so loud that the patient thought his tinnitus become significantly worse.The feedback test was aborted and the hcp did not go through it completely.According to the hcp's records, the patient did not see an ent specialist afterwards.However, it says that the patient visited a neurologist due to sleep disorder.The hcp does not have any measurements of patient's tinnitus after the incident as the patient did not want to come back to the hcp.The customer has described to the hcp the level of his tinnitus as severe and life-limiting (sleep disturbances, withdrawal from everyday life, he apparently no longer participates at all, repeated palpitations, depression, pain in the ears).The hcp confirmed that they did not observe any apparent malfunction.The investigation is ongoing and findings are pending.
Event or Problem Description
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.
Additional Manufacturer Narrative
The manufacturer was not able to receive the hearing instrument for the analysis and obtain more information about the patient's outcome as the patient does not want come back to the clinic.In the consecutive follow up, the hcp confirmed that the fitting proceeded as normal without any abnormalities.The new earpieces were made by a different laboratory (not sonova ag).The name of the earpiece manufacturer was not confirmed.The manufacturer checked the patient's fitting files obtained from the hcp.There was no particular abnormalities detected in the fitting files.Based on the files, the mpo was increased above 132 db, which is set by the hcp depending on the patient's needs and hearing loss level.As this mpo is considered high, the fitting software gives a warning that needs to be acknowledge in order to proceed with the fitting.The loudness of the feedback test depends on the mpo fitting of the hearing instrument.There is no service history for patient's hearing instrument, which confirms that the device was not serviced before.The manufacturer reviewed the technical documentation.The feedback test is checked as part of the hearing aid verification.No bugs have been detected.The risk file already contains a risk concerning high sound pressure level being delivered during feedback test.The fitting software integrates risk control measures such as the sound pressure level of the audio test signal is lower than 132 db spl, an information to the hcp prior to the test initiation that the hi will produce a test signal that can be cancelled at any time and the fitting software provides a user interface to immediately mute the audio test signal.The ifu specifies that the fitting software is intended to be used by qualified hearing care professionals and contains important safety information concerning loud sounds.The review of similar incidents confirmed that the manufacturer has not recorded any similar cases in the last 3 years globally for any of sonova ag hearing instruments and software.

• Brand Name: PHONAK BOLERO M70-PR
• Common Device Name: HEARING AIDS, BEHIND-THE EAR
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 22306712
• Report Number: 3005085999-2025-00012
• Device Sequence Number: 8568122
• Product Code: OSM
• UDI-Device Identifier: 07613275689783
• UDI-Public: (01)07613275689783
• 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): 05/26/2025

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: Health Professional
• Device Model Number: 0500676P3
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2022
• 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 Age: 80 YR
• Patient Sex: Male