MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO M30-312; HEARING AID, RECEIVER IN CANAL (RIC)

Model Number	0500491P3
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonova was notified about an incident in which haring aid's receiver stuck in the patient's ear.Patient had to go to the emergency room to remove the receiver from her ear.She is now afraid to wear her his.
Additional Manufacturer Narrative
The manufacturer initiated the investigation.10: sonova requested broken part for analysis.4110: sonova is actively monitoring and trending complaints on a regular time interval in addition we checked data from the last 3 years and there have been no trends observed.4111: sonova reached out to the initial reporter with additional questions.The hcp stated that this receiver was in use since on (b)(6) 2023.The hcp did not provide an answer to the circumstances of the incident.Image analysis: sonova received an image of the broken receiver.The image shows that the back housing with cable detached from the receiver's body.As a result of the detachment, the receiver is no longer functional and may be more difficult to remove from the ear than if the cable were still attached.The dome is still attached to the receiver.Labelling/document review: user guide provides warning instructing patients to consult a physician if a dome remained in the ear.The user guide shows how to correctly use hearing aid, e.G.Place and remove it from behind the ear, as well as it describes basic care and maintenance steps.This is considered adequate.The risk file already considers and addresses a risk of component stuck in the ear.Analysis of service records: service history reviewed showed that these hearing aids were not serviced before.Further analysis: during production, receivers undergo several quality control inspections.The amount of glue and correct alignment of the housing parts is checked visually for every receiver (100% sampling).The glue area is inspected a second time with a microscope (100% sampling rate.The design meets requirements from iec 60601-2-66 that requires the detachable parts to withstand min.3n pull force.Supplementary reports will be submitted upon availability of new information.
Additional Manufacturer Narrative
10: the receiver was manufactured in 2022 and is estimated to have been stored at the hcp for approximately three years.It is not possible to confirm how the receiver was handled during storage (e.G., environmental conditions).Visual inspection identified a clean cut between the receiver wire and the portion inserted into the ear.The origin of the cut is unknown.External factors (e.G., storage conditions, handling by the user etc.) cannot be ruled out as having caused or contributed to the observed damage.The hearing aid was also checked and is functioning as expected.No issues were identified.4111: clarification - the receiver was in use for 1 month and not since 2023 as stated in the initial report.The hcp stated that the patient is handling the product gently.Conclusion: the root cause is not conclusive.There is no indication that the break occurred due to design or manufacturing issues.It is possible that external factors have contributed to receiver breaking.The occurrence of similar incidents is low and there was no trend observed.Sonova will keep monitoring the market for trends.

• Brand Name: PHONAK AUDEO M30-312
• Common Device Name: HEARING AID, RECEIVER IN CANAL (RIC)
• 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: 24077719
• Report Number: 3005085999-2026-00001
• Device Sequence Number: 13207328
• Product Code: OSM
• UDI-Device Identifier: 07613275643624
• UDI-Public: (01)07613275643624
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/30/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0500491P3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AUDÉO M30-312 (B)(4).; COMPONENT: RECEIVER SDS 5.0 2S RIGHT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female