MAUDE Adverse Event Report: WSA SUZHOU, LTD. SIGNIA; INSIO 1PX CIC

Catalog Number	10946779
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In this event, customer reported a sharp loud sound from left hearing aid when he was inserting the aid.This was followed by pain in left side of head and ongoing tinnitus.Customer was assessed by hearing care professional (04/29/2024) and left ear was showing some minor conductive decline, as compared to his testing in march.Clinician conducted hearing assessment and tympanometry revealed type b tympanograms, consistent with a conductive component to hearing loss.Also observed was an active ear infection and the customer was prescribed antibiotics to treat infection; consistent with the tympanometric results.The maximum output spl (sound pressure level) from the device is limited by safety limiter.Results of technical investigation: left hearing aid was returned for investigation.Based on acoustic test result, hearing aid is functioning within specification.The maximum gain that the ha can give is only 52.1 decibel and max ospl90 is 111.5 decibel, which is within the device specification.The max output level is low by industry standards and would not be associated with a conductive hearing loss.Internal audiologist evaluation: the type b tympanogram (consistent with a conductive issue) suggests patient has some middle ear pathology, and this was confirmed by his physician.The type b tympanometry result is indicative of the eardrum not moving well, which can often be related to fluid in the middle ear.This condition would act to further dampen the sound during transfer in the ear.
Additional Manufacturer Narrative
Cross-reporting case from australia.

• Brand Name: SIGNIA
• Common Device Name: INSIO 1PX CIC
• Manufacturer (Section D): WSA SUZHOU, LTD.; no. 120 su tong road; suzhou jiangsu, CN 2 1502; CH CN 215021
• Manufacturer Contact: la-shaunda joseph ; 101 wood avenue; 7th floor; iselin, NJ 08830 ; 5617859321
• MDR Report Key: 19510450
• Report Number: 3007595838-2024-00037
• Device Sequence Number: 19696914
• Product Code: OSM
• UDI-Device Identifier: 04056839035788
• UDI-Public: 04056839035788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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 Catalogue Number: 10946779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male