BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 10940099 · Received December 3, 2020

    Report

    Report Number
    3005650109-2020-00052
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Report Date
    August 24, 2021
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05704819290175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: PHONE 12, IOS 14.2. PATIENT REPORTS THAT, EVERY 3RD OR 4TH PHONE CALL, HE HEARS A LOUD DISTORTION. PATIENT ALSO REPORTS THAT CALLS OCCASIONALLY DROP FROM ONE EAR. NO HARM OR MEDICAL INTERVENTION WAS REPORTED. . INVESTIGATION CONSIDERATION: THIS IS INDEED A KNOWN ISSUE IN IOS14 ON IPHONE12. THE HI WORKS AS SPECIFIED, SO THE NORMAL SAFETY SYSTEMS ARE IN PLACE AND FUNCTION. IE THE PROGRAMMED MPO IS NOT EXCEEDED. HOW LOUD THE SYSTEM CAN GET IS DEPENDING ON: 1) SETTING OF THE VOLUME ON THE PHONE. 2) GAIN SETTING. 3) MAX OUTPUT SETTING. WORST CASE THE SIGNAL EQUATES AN INPUT OF 100DBSPL AMPLIFIED AND LIMITED BY THE NORMAL COMPRESSOR SETTINGS. CLINICAL EVALUATION OF THE EVENT: EVERY 3RD OF 4TH CALL, A LOUD DISTORTION IS HEARD, AND CALL DROPS. THIS IS REPORTEDLY A KNOWN ISSUE, AND WHILE ANNOYING IS HIGHLY UNLIKELY TO CAUSE HARM TO THE PATIENT DUE TO THE SAFETY SYSTEMS IN PLACE IN THE HEARING AIDS. CLINICAL CONCLUSION ON THE CASE IS THAT - EVEN THOUGH UNPLEASANT - IT IS EVALUATED UNLIKELY THAT THE REPORTED EVENT WOULD BE HARMFUL TO RESIDUAL HEARING. 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. AFTER COMPLETION OF THE INVESTIGATION, THIS CASE IS NO LONGER CONSIDERED REPORTABLE TO FDA.

    Description of Event or Problem · 0

    AS REPORTED BY LOCAL CUSTOMER SERVICE: LOUD DISTORTION WHEN STREAMING PHONE CALLS; PHONE CALLS OFTEN SOMETIMES SWITCH BETWEEN EARS. IPHONE 12, IOS 14.2. PATIENT REPORTS THAT, EVERY 3RD OR 4TH PHONE CALL, HE HEARS A LOUD DISTORTION. IT WAS LOUD ENOUGH THAT I COULD HEAR IT OVER THE PHONE. PATIENT ALSO REPORTS THAT CALLS OCCASIONALLY DROP FROM ONE EAR. THIS PROBLEM DID NOT OCCUR W/ PATIENT'S PREVIOUS IPHONE. PAIRED DEMO AIDS TO THE IPH 12, SAME THING OCCURRED. DISCUSSED THAT IPH 12 IS NOT ON OUR COMPATIBILITY LIST, IS STILL BEING TESTED. CUSTOMER UNDERSTOOD. GAVE CUSTOMER APPLE ACCESSIBILITY PHONE#. PATIENT WOULD STILL LIKE TO HAVE HAS SENT IN, CUSTOMER WILL SEND ATTN: QE. QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? NO. HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO. PLEASE CHOOSE THE DURATION OF THE SOUND? LONGER THAN 10 SECONDS. WHAT TYPE OF RECEIVER? HIGH POWER.

    Additional Manufacturer Narrative · 1

    COMMENT BY MANUFACTURER: POTENTIALLY THE REPORTED LOUD SOUND COULD HAVE DAMAGED THE REMAINING HEARING OF THE USER/PATIENT, BUT NO SUCH HARM IS REPORTED IN THIS CASE. ACC TO OUR INTERNAL PROCEDURE ITS MANDATORY FOR US TO INVESTIGATE, WHEN ITS A POWERFUL DEVICE, DESPITE NO HARM HAS BEEN REPORTED. THIS IS DUE TO POSSIBLE MALFUNCTION, AND RISK FOR IT COULD CAUSE OR CONTRIBUTE. WE WILL NOT BE ABLE TO FINALIZE INVESTIGATION IN TIME FOR THE 30 DAY TIME LIMIT, WHY THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY LOCAL CUSTOMER SERVICE: LOUD DISTORTION WHEN STREAMING PHONE CALLS; PHONE CALLS OFTEN SOMETIMES SWITCH BETWEEN EARS. (B)(6); PATIENT REPORTS THAT, EVERY 3RD OR 4TH PHONE CALL, HE HEARS A LOUD DISTORTION. IT WAS LOUD ENOUGH THAT I COULD HEAR IT OVER THE PHONE. PATIENT ALSO REPORTS THAT CALLS OCCASIONALLY DROP FROM ONE EAR. THIS PROBLEM DID NOT OCCUR W/ PATIENT'S PREVIOUS (B)(6). PAIRED DEMO AIDS TO THE IPH 12, SAME THING OCCURRED. DISCUSSED THAT IPH 12 IS NOT ON OUR COMPATIBILITY LIST, IS STILL BEING TESTED. CUSTOMER UNDERSTOOD. GAVE CUSTOMER APPLE ACCESSIBILITY PHONE#. PATIENT WOULD STILL LIKE TO HAVE HAS SENT IN, CUSTOMER WILL SEND ATTN: QE. QUESTIONNAIRE: WAS THE SOUND PAINFUL AND/OR DID IT CAUSE HARM TO THE PATIENT OR OTHER PERSON? NO. HAS THE PATIENT BEEN IN CONTACT WITH A PROFESSIONAL? NO. PLEASE CHOOSE THE DURATION OF THE SOUND? LONGER THAN 10 SECONDS. WHAT TYPE OF RECEIVER? HIGH POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404973 GN RESOUND LT762-DRW,RESOUND LINX3D 7 OSM GN HEARING A/S LT762-DRW,RESOUND LINX3D 7,GN RESOUND 05704819290175

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability