MAUDE Adverse Event Report: SONOVA AG PHONAK; LYRIC4

Model Number	078-0063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A 90-year-old patient, long time user of the lyric device, had a new device inserted in (b)(6) 2022.The insertion depth of the device in the ear canal was 7mm.The patient has removed the device after about 2 weeks wearing time due to pain in the ear but did not have the ear checked.On the (b)(6) 2022, when the patient came to get the device replaced, the hcp has identified "pit in his ear" at about 5mm in the canal.The pit was filled with debris.The hcp has referred the patient to an otolaryngologist however, the patient went to a family physician who did not have any concerns about the state of the patient's ear.During the next visit to hcp for lyric replacement, the state of the ear has worsened.On (b)(6) 2022, the patient has visited otolaryngologist, who cleared the debris, and concluded that the ear canal has eroded through cartilage to the bone, and the tissue was necrotic.The patient was diagnosed by the otolaryngologist with externa auditory cholesteatoma, which according to the otolaryngologist was caused by the use of lyric.The doctor treated the patient's ear with topical antibiotic and indicated that it should heal.He recommended to stop using lyric and fit with a different model of hearing aids once ear has healed.
Additional Manufacturer Narrative
The preliminary analysis does not indicate that the event occurred due to a failure of the device to perform as expected.Based on the information provided in the case it cannot be excluded that lyric4 has contributed to the event.The delay in professional treatment from august to november was likely to contribute to the severity of the event.The patient did not contact hcp upon removal of the device due to pain, and addressed a family doctor instead of otolaryngologist upon the referral.The lyric device was discarded by patient in august and therefore device analysis can not be performed.Similar events are subject to ongoing monitoring.
Additional Manufacturer Narrative
The delay in professional treatment from august to november has contributed to the event.Moreover, instruction for use includes a warning that the patient needs to contact hearing care professional in case of pain beyond initial discomfort.The patient has undergone a treatment involving debridement and topical anibiotics.On 24.02.2023 the company was informed that the patient has been cleared to use daily wear hearing aids.This is the final report.

• Brand Name: PHONAK
• Common Device Name: LYRIC4
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 16094709
• Report Number: 3005085999-2023-00001
• Device Sequence Number: 6669145
• Product Code: ESD
• UDI-Device Identifier: 07613389250893
• UDI-Public: 07613389250893
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 12/07/2022

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: 078-0063
• Device Catalogue Number: 078-0063
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male