BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELTONE IMAGINE 6

    MDR report key: 12757691 · Received November 7, 2021

    Report

    Report Number
    3005650109-2021-00015
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 11, 2021
    Report Date
    March 4, 2021
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296194223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656959 BELTONE IMAGINE 6 HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S IMG663-DRWC,IMAGINE 6,BELTONE 05708296194223

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Disability