MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	21197320
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Caustic/Chemical Burns (2549)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a user experienced a chemical burn on the back of his right ear, after a hearing aid battery leaked.The user went to the emergency room after experiencing the burn.It is unknown whether any medical intervention was prescribed.Despite attempts it has not be possible to obtain further information on this complaint.No further follow up is not available or expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a device history record review has been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: it was reported that a user allegedly experienced a chemical burn on the back of his right ear, after a hearing aid battery leaked.The user went to the emergency room after experiencing the alleged burn.It was reported that he was there for 9 hours, but it is unknown whether this time was spent in the waiting room, or undergoing treatment.It is unknown whether any medical intervention was prescribed during the visit.Despite attempts it has not be possible to obtain further information on this complaint.An invesitgation of the affected hearing aid found white particulates, resembling that of the salt which forms when the electrolyte of the battery is exposed to air.Using a scanning electron microscope, it was possible to confirm the presence of zn (zinc), k (potassium) and o (oxygen) on the interior surface of the battery compartment.The electrolyte of the hearing consists of potassium hydroxide (koh) and zinc, so in case of battery leakage, you would expect these elements present on affected surfaces.Potassium can also be found in sweat, though zinc confirms that the substances in the battery has leaked from the battery.The battery was not returned, and its whereabouts are unknown, hence the root cause cannot be confirmed.Leakage from batteries can result from battery explosion or the battery can have a hole that allows material to leak out.Zinc-air and silver zinc batteries used with hearing aids are known to have a low risk of leaking.Zinc-air batteries are used in the non-rechargeable hearing aids and silver zinc batteries are used in the z-power solution.The risk increases if the battery is exposed to excessive heat.Even without excessive heat, in rare cases, gas can be generated inside the battery and if the pressure builds up to more than the cell can withstand, a rupture can occur.Sometimes this is accompanied by a brief loud sound; hence the word "explosion".There are no combustible chemicals in zinc-air and z-power batteries, but an alkaline electrolyte.All materials should be put in a container and care should be taken to avoid skin being exposed to ruptured battery.If skin is exposed, it should be flushed with lukewarm water for at least 15 minutes.Immediate medical attention should be sought if eyes are exposed.Battery leakage can in some cases be prevented if the hearing aids are dried out after use by opening the battery door.Further, batteries that are expired are more likely to leak.The user guide includes recommendations on both hearing aid drying and only to use batteries with a remaining shelf life of one year or more.The user guide contains information only to use quality batteries as well as rinsing with lukewarm water if exposed to battery leakage.If a battery or a hearing aid is accidently ingested, an immediate emergency appointment should be made.Risk assessment: risks related to substances leaking from hearing aid batteries, are generally known, considered in risk analysis and mitigated.This risk is deemed to be acceptable.Device investigation concluded: an invesitgation of the affected hearing aid found white particulates, resembling that of the salt which forms when the electrolyte of the battery is exposed to air.Using a scanning electron microscope, it was possible to confirm the presence of zn (zinc), k (potassium) and o (oxygen) on the interior surface of the battery compartment.The electrolyte of the hearing consists of potassium hydroxide (koh) and zinc, so in case of battery leakage, you would expect these elements present on affected surfaces.Potassium can also be found in sweat, though zinc confirms that the substances in the battery has leaked from the battery.The battery was not returned, and its whereabouts are unknown, hence the root cause cannot be confirmed.Manufacturer's investigation is final.This is a combined (initial and final) report.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 25374122
• Report Number: 3005650109-2026-00015
• Device Sequence Number: 15754175
• Product Code: OSM
• UDI-Device Identifier: 05708296178612
• UDI-Public: 05708296178612
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 21197320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male