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

Model Number	RLY2ITC-DW-MP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer has not received the device yet.Investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
18-apr-2023: it was reported: "unsure if the battery acid has caused any internal circuit damage".User didn't put aid on as noticed something was leaking.No harm to user was reported.
Event or Problem Description
18-apr-2023: it was reported: "unsure if the battery acid has caused any internal circuit damage".User didn't put aid on as noticed something was leaking.No harm to user was reported.(b)(6) 2023: disposable batteries were used.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer has not received the device yet.Investigation is still in progress; a final report will be submitted upon completion.16-may-2023: the device has not been returned for investigation.Therefore, no device investigation possible.Technical investigation concluded: a device history record review has been completed.No deviation or changes were found during the manufacturing of the device.The clinical investigation concluded: clinical evaluation for the device family evaluates the risk of leakage from batteries.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.There are no new clinical aspects (e.G., unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk register conclusion: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.Manufacturer's investigation is final.This is a final report.

• Brand Name: BELTONE
• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16766918
• Report Number: 3005650109-2023-00052
• Device Sequence Number: 6398167
• Product Code: OSM
• UDI-Device Identifier: 05708296208043
• UDI-Public: 05708296208043
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RLY2ITC-DW-MP
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Female