MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4 (S); AIR-CONDUCTION HEARING AID, IN-CANAL

Model Number	0780069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ear Pain (4812); Ear infection (4813)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted an investigation.Interview/follow up: initial reported stated that the patient is (b)(6) with dementia.The patient heard very well for 2 days and then a caregiver noted she was no longer hearing.Removal at 2 week follow-up appt was extremely difficult, resulting in bleeding, hematomas, and revealing infection in both ears.The patient went to the urgent care the day of and was given drops.It's all cleared up now.The patient will not continue with lyric and will go back to her original ric hearing aids.Device analysis: lyric is a single use device and is usually discarded and hence is not available for the analysis.Analysis of service/ maintenance records: lyric is a single use device and does not undergo service.It does not require maintenance.Clinical impact: the device is designed to be worn deep within the ear canal, effectively sealing it as intended.However, this sealing can potentially lead to moisture accumulation in the space between the device and the eardrum.Such moisture retention may compromise skin integrity, creating a moist and dark environment that is conducive to bacterial growth.This environment can occasionally result in skin irritations or infections.Related to the deep inserted extended wear of lyric, symptoms such as abrasions, bleeding, ulcers and otitis externa tend to occur most commonly as a result of traumatic insertion, sizing error, poor placement or patient manipulation.It should be also noted that ear infection, e.G.Otitis externa or media, is a relatively common condition that can occur independently of hearing aid use.Patients are expected to fully recover from ear infections and abrasions, bleeding and ulcers as it was also confirmed in this case.Labeling review: the ifus are deemed complete and sufficient.The fitting guideline for the hcps provides instructions on proper lyric removal from the patient's ear, among others, to apply gentle, circular motion.This ifu also provides direction for what to do in case of resistance e.G.To stop pulling, gently peel the seals away from the skin and if resistance continues, apply lubrication.Both hcp's and patient's ifu list common side effects, e.G.Moisture, blisters, pain, and provide necessary warnings, as well as primary criteria for the referral of a patient for a medical/specialist opinion or treatment, including pain or discomfort, inflammation and other abnormalities.It is recommended to let the ear rest and not to insert a new lyric directly after if blood was observed upon removal.Risk assessment: the risk file already contains and addresses the risk of both self-resolving and non-self-resolving soft tissue injuries.It is deemed adequate.Trend reporting/similar complaints: sonova ag is actively trending complaints and monitoring products on the market on a regular intervals.We analyzed similar complaints from the last 3 years.We did not record a positive trend for this or similar issues (infection, bleeding, abrasion etc.).
Event or Problem Description
It was reported to the manufacturer that the removal at 2 week follow up appointment was extremely difficult, resulting in bleeding, hematomas and revealing infection in both ears.

• Brand Name: PHONAK LYRIC4 (S)
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-CANAL
• 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: 23540815
• Report Number: 3005085999-2025-00037
• Device Sequence Number: 9683635
• Product Code: ESD
• UDI-Device Identifier: 07613389603293
• UDI-Public: (01)07613389603293
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 10/24/2025

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: Lay User/Patient
• Device Model Number: 0780069
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Unknown