MAUDE Adverse Event Report: EARLENS CORPORATION EARLENS CONTACT HEARING SOLUTION; TYMPANIC LENS

Model Number AS00750-03

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Perforation (2001)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The left earlens tympanic lens was received at earlens corporation in a contact lens case without oil and visual inspection was performed.Moderate cerumen and epithelial plaque was concentrated on the anterior region and mild build-up on the inferior region of the chassis was noted; the consistency was crusty.There was also a layer of crusty cerumen on top of the inferior side of the lens' microactuator membrane.No sharp edges were observed on the perimeter platform of the lens.It was the physician's opinion that the persistent moisture in the ear macerated the already thin area creating the perforation.The physician noted that the perforation occurred in the monomeric region of the tympanic membrane.It should be noted that a monomeric tympanic membrane is a contraindication to use of the earlens system.The earlens contact hearing solution physician instructions state the following as a contraindication: the patient must not have any known or active medical issues that would preclude having a hearing device, including: an abnormal tm (deemed perforated, inflamed or has dimeric or monomeric area, or in any other way abnormal).

Event Description

A left earlens tympanic lens was placed successfully on (b)(6) 2019.At the time of the placement, the patient had no sign of infection.On (b)(6) 2019, the patient returned for an otoexam and the physician noted that the lens was in good position and the patient reported to be hearing well with the earlens system.On (b)(6) 2019, the patient came into the clinic reporting that he was not hearing as well; he stated that the onset was gradual.There was no report of pain.The patient confirmed that he used the mineral oil spray in the ear canal nightly.During the otoexam on (b)(6) 2019, it was noted that the ear canal was moist with mineral oil, and there was also moist keratin and cerumen noted.Slightly purulent oil pooling was noted inferiorly around the tympanic lens platform (chassis and motor) obscuring view of the tympanic membrane (tm).The lens was also displaced about 0.5 mm.When the pooled oil was suctioned, a small perforation of the tympanic membrane was seen under the chassis.Per the physician, it was not in a location where the lens would have touched it, if the lens was in place, or in a location where the displaced lens was currently touching.The lens was removed and moist debris was suctioned from the surface of the tm.The middle ear was fairly dry.The perforation was about 5% of the tm (the prior monomeric area was 20%).The ear was rinsed with floxin and then a paper patch was placed on the tm.Floxin ear drops were also prescribed.On (b)(6) 2019, the patient was seen at the clinic and the physician noted that the infection was resolved, the perforation had healed well and the tympanic membrane was intact and moving well with pneumatic pressure.Of note, the patient did have a perforation in this ear in the past prior to wearing the earlens device that healed spontaneously.Prior images showed a monomeric tympanic membrane in the area of the current perforation.It should be noted that a monomeric tympanic membrane is a contraindication to use of the earlens system.The earlens contact hearing solution physician instructions state the following as a contraindication: the patient must not have any known or active medical issues that would preclude having a hearing device, including: an abnormal tm (deemed perforated, inflamed or has dimeric or monomeric area, or in any other way abnormal).

• Brand Name: EARLENS CONTACT HEARING SOLUTION
• Type of Device: TYMPANIC LENS
• Manufacturer (Section D): EARLENS CORPORATION; 4045a campbell ave; menlo park CA 94025
• Manufacturer (Section G): EARLENS CORPORATION; 4045a campbell ave; menlo park CA 94025
• Manufacturer Contact: rasean butler ; 4045a campbell ave; menlo park, CA 94025 ; 6507394427
• MDR Report Key: 9451049
• MDR Text Key: 184905652
• Report Number: 3010863048-2019-00001
• Device Sequence Number: 1
• Product Code: PLK
• UDI-Device Identifier: 08500130070284
• UDI-Public: (01)08500130070284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AS00750-03
• Device Catalogue Number: IBK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR