MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO I90-SPHERE; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-1029-P1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Ear Pain (4812)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a follow up to gather more information on the incident.It has been established that the patient tried to remove the object herself and it resulted in pain and bleeding.On (b)(6) 2025, at the hospital a doctor tried to remove the cerustop by rinsing the ear canal under light anaesthesia (propofol).Doctor states that the wax filter was not visible after rinse.Patient was prescribed antibiotics (ciproxin) for 7 days.The next day on (b)(6) 2025, the patient went to her hcp, who confirmed the wax filter is still in he ear canal.Patient was complaining of pain in the ear canal and a sensation of "blocked ear".Then patient went to another hospital where a doctor confirmed the presence of the wax filter, touching the tympanic membrane.Wax filter was extracted under light anaesthesia (lidocaine spray) and several "delicate tries".After removal ear canal the observation was made to state bleeding flaps of skin.Rinse with oxygenated water applied.Follow up on (b)(6), stated the patient is now okay (no pain) and does not complaint about her ears.Ear canal observation: no bleeding, good tympanic membrane.The device was not available for investigation.Manufacturer has analysed the pictures provided to this case though and the modeling files of the custom cshell.It has been stated that it was the cerustop bushing including the filter that came off.Modelling files confirm the modelling was done at the limit, as the planar area at the shell tip is at the minimum for a robust placement and gluing interface of the bushing.This is seen as a slight deviation.Follow up with the audiologist states the defective cshell was repaired by the audiologist (re-glued) and a new cshell has been ordered for the patient.The patient has left the country and moved to another one so the device subject to this report is not available for evaluation.Manufacturing records for the cshell have also been checked.Cshell udi: (b)(4), cshell manufacturing date: 01-sept-2025.It is confirmed there is no record of production rework order for this product nor was there any relevant nonconformity recorded at the time of this order production.The product has passed qc checks accordingly.Manufacturer confirms that cerustop filter is a detachable part by design.Its function is to protect the receiver from earwax and debris accumulation.Cerumen filers need to be replaced regularly to prevent acoustic sound deterioration.An applicable risk on the detachable parts of the device remaining in the ear canal is present in the risk assessment of this device.Risk control measures, including appropriate warning in the user guide, are implemented.The user guide also contain a dedicated instruction on the filter replacement method.When handled improperly (cleaning method, cleaning agent, filter replacement), the bushing of the filter may weaken and not hold well anymore.User guide of the device contains proper handling instructions.The manufacturer checked for similar complaints in the last three years and there have been no trends identified.The manufacturer will keep observing for trends.This is the final report.
Event or Problem Description
It has been brought to manufacturer's attention that cerutop (wax filter) of cshell does not stay in holder and has remained in the patient's ear canal.The patient went to hospital where various medications have been administered including general anaesthesia.Patient experienced pain and bleeding.Cerustop has eventually been removed with irrigation.Cshell sn: (b)(6).

• Brand Name: PHONAK AUDEO I90-SPHERE
• Common Device Name: HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 24412003
• Report Number: 3005085999-2026-00003
• Device Sequence Number: 5878010
• Product Code: OSM
• UDI-Device Identifier: 07613389686593
• UDI-Public: (01)07613389686593
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 050-1029-P1
• 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: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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: Female