MAUDE Adverse Event Report: GN HEARING A/S BELTONE IMAGINE 6; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	IMG663-DRWC,IMAGINE 6,BELTONE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: hcp's patient reports "unbearable" tinnitus after removing these img 6/63's with open dome mp receivers.She had or 3/64 with np receivers and open domes without this.Patient has discontinued use of the units.The hcp will try open dome lp receivers.Hearing aids are removed from ears and tinnitus becomes present.Hcp reported the patient returned to his office (b)(6) 2021.The tinnitus is still present even with discontinuation of use of the new hearing aids.Original or3/64 refitted.Wearing on left side only due to eam irritation r ear cerumen removal.Additional information received on 26oct2021: patients l ear canal looks much better per the redness i saw last week.She put the old hearing aids back in her ears and the tinnitus goes away, but comes right back at night when she pulls them out.Patient has not seen a physician.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Based on the clinical assessment of the case and risk assessment, the case is considered no longer reportable to fda, as it is highly unlikely that the hi should have caused worsening in tinnitus.Summary of investigation findings: the case has been reviewed from a clinical perspective.Customer reported: patient reports "unbearable" tinnitus after removing these img 6/63's with open dome mp receivers.-she had or 3/64 with np receivers and open domes without tinnitus.Patient has discontinued use of the units.The hcp will try open dome lp receivers.Hcp will send in the hearing aids with a qa routing form if they are returned.Hcp reported the patient returned to his office (b)(6) 2021.The tinnitus is still present even with discontinuation of use of the new hearing aids.It is reported that when patient puts in the original aids the tinnitus goes away, but comes right back at night when she pulls them out.Clinical evaluation of the event: high sound pressure can cause tinnitus.However, the attached noah-file shows that the devices have not been fitted to cause that high a sound pressure (maximum 16 db insertion gain).Further, the maximum output is 114 db spl.Tinnitus is common together with hearing loss.During a fitting and during the first months with hearing aids, there is a lot of attention being put to the patient's hearing and how sound is perceived.This attention could potentially have been the trigger for the patient's experience, however it is not possible to conclude this with certainty.The clinical conclusion in regard to tinnitus is that the hearing aids are highly unlikely to have caused the worsening in tinnitus in regard to high sound pressure or in regard to too much amplification of sound.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.Dhr review: device manufactured accepted to specifications, all inspections passed and no deviations / changes implemented during the production.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.

• Brand Name: BELTONE IMAGINE 6
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• Manufacturer (Section G): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 12757691
• Report Number: 3005650109-2021-00015
• Device Sequence Number: 17004057
• Product Code: OSM
• UDI-Device Identifier: 05708296194223
• UDI-Public: 05708296194223
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/04/2021

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: IMG663-DRWC,IMAGINE 6,BELTONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Prefer Not To Disclose