MAUDE Adverse Event Report: EARGO, INC. EARGO; HEARING AID, AIR CONDUCTION

Model Number	N/A
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Hearing Loss (1882)
Date of Event	11/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Eargo has requested that the patient obtain a hearing test post sample removal.Because test results are not yet available, the reported event cannot be confirmed.While eargo's complaint investigation is ongoing, this event is being filed as an mdr in an abundance of caution to ensure full compliance with 21 cfr part 803.Eargo will supplement this mdr if/when additional information becomes available.The sizing sample intended to be non-functional has not been returned; therefore, product failure analysis was not possible.The specific lot number could not be distinguished from multiple lots shipped to customers that day.However, a review of all possible lot history records for the sample was performed and no nonconforming material reports were initiated for these lots.The sample provided is intended for sizing purposes and single use only.The brochure containing the samples and the label placed on each sample were reviewed.The brochure refers to the eargos as "samples" and provide instructions on how to obtain "real eargo devices." the label on each sample states "non-working sample, single use only, and read usage instructions.".
Event or Problem Description
Following the use of the company's sizing sample intended to be non-functional, the patient alleges her hearing is reduced and now experiences pain, ringing in her ears, and severe discomfort.When the patient received her sizing samples (sizes 12 and 15), she observed that the size 15 sample was missing a removal thread.Patient also indicates that the size 15 sample was big and did not fit inside her ear.Patient states that even though there was no thread on the size 15 sample, she did not anticipate having a problem removing it as it was too big.Patient also indicates that she was initially able to remove it easily from her ear.On the third day of use, patient states that she was unable to remove the sample from her ear.Her physician referred her to an ent specialist who was able to remove it.
Additional Manufacturer Narrative
Eargo has received the patient's audiograms that were performed pre- and post- reported event and reviewed by the company's medical (ent).The pre-event audiogram was performed at (b)(6) on (b)(6) 2015 and the post-event audiogram was performed on (b)(6) 2016 at (b)(6).Both audiograms report a mild to moderate hearing loss.Minor differences found between the audiograms, 5db - 20db, are well within the test/retest variability of pure tone audiograms, especially with different examiners.Both audiograms show very good word discrimination results.Based on the audiograms reviewed, there is no evidence that there was hearing damage caused by the reported event.Information from initial report: the sizing sample intended to be non-functional has not been returned; therefore, product failure analysis was not possible.The specific lot number could not be distinguished from multiple lots shipped to customers that day.However, a review of all possible lot history records for the sample was performed and no nonconforming material reports were initiated for these lots.The sample provided is intended for sizing purposes and single use only.The brochure containing the samples and the label placed on each sample were reviewed.The brochure refers to the eargos as "samples" and provide instructions on how to obtain "real eargo devices." the label on each sample states "non-working sample, single use only, and read usage instructions.".

• Brand Name: EARGO
• Common Device Name: HEARING AID, AIR CONDUCTION
• Manufacturer (Section D): EARGO, INC.; 295 n. bernardo avenue; suite 100; mountain view CA 94043
• MDR Report Key: 5371893
• Report Number: 3010841212-2016-00001
• Device Sequence Number: 62822
• Product Code: ESD
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2015

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: N/A
• Device Catalogue Number: 99-0009-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/18/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2016
• Supplement Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other