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IFU00021vH 

 

 

 

 

 

 

1.

 

Introduction ......................................................................................................... 2

 

2.

 

Wireless Earlens Light-Driven Hearing Aid Device Description ..................... 2

 

3.

 

Indications for Use .............................................................................................. 3

 

4.

 

Fitting Range ....................................................................................................... 3

 

5.

 

Contraindications ................................................................................................ 3

 

6.

 

Warnings .............................................................................................................. 4

 

7.

 

Precautions .......................................................................................................... 4

 

8.

 

Clinical Study Results ......................................................................................... 5

 

9.

 

Operating Instructions ........................................................................................ 7

 

10.

 

Operating Specifications .................................................................................... 9

 

11.

 

Glossary of Terms ............................................................................................. 10

 

12.

 

Graphic Symbols Contained in Device Labeling ............................................ 10

 

13.

 

Laser Certification ............................................................................................. 11

 

 

 

 

 

 

 

 

 

 

                                     Wireless Earlens Light-Driven Hearing Aid Physician Instructions 

Summary of Contents for Light Driven

Page 1: ...4 Fitting Range 3 5 Contraindications 3 6 Warnings 4 7 Precautions 4 8 Clinical Study Results 5 9 Operating Instructions 7 10 Operating Specifications 9 11 Glossary of Terms 10 12 Graphic Symbols Cont...

Page 2: ...an It is placed at the end of the ear canal on the skin around the TM 2 2 Photon Processor and Light Tip The Processor is directly connected to the Light Tip via the cable Figure 3 The Processor is de...

Page 3: ...ring impairment who can benefit from amplification The device can provide the full spectrum of amplification that includes 125 Hz 10 000 Hz 4 Fitting Range The Earlens Light Driven Hearing Aid provide...

Page 4: ...e discharge from the ear or persistent discomfort or any other problems Should the Processor become unusually warm or hot the patient should promptly remove it discontinue use and contact their hearin...

Page 5: ...rical equipment such as cell phones metal detectors microwaves RFID systems and commercial theft detection systems also known as electronic article surveillance EAS may interfere with the Earlens Hear...

Page 6: ...significant improvement in mean aided word recognition at 30 days post placement when compared to the baseline unaided condition measured prior to placement The average baseline unaided score was 52 a...

Page 7: ...ure 4 AEs or the inspection process pre impression 2 AE Two of the related AEs were attributed to Light Tip fit and both were resolved after Light Tip modification One subject continues to report a se...

Page 8: ...refully place the device in a dish of mineral oil for soaking b Thoroughly clean the ear canal anterior sulcus and TM using cotton swabs mineral oil and suction as needed Remove any debris including e...

Page 9: ...tions and replace following the Cleaning and Preparing Lens for Reinsertion operating instructions Once Lens is replaced assess if the suspected performance issue is resolved e g system Light Calibrat...

Page 10: ...2 5 3 9 Keep Dry ISO 15223 1 2012 5 3 4 IP21 International Protection Code against ingress of solid foreign objects 12 5mm diameter and vertically falling water drops when enclosure tilted up to 15 IE...

Page 11: ...Light Driven Hearing Aid complies with 21CFR 1040 10 and 1040 11 Manufacturer Ref ISO 15223 1 2012 5 1 1 Earlens Corporation Inc 4045A Campbell Ave Menlo Park CA 94025 European Authorized Representat...

Page 12: ...IFU00021vH 12 Apple the logo AirPlay iPhone iPad iPod are trademarks of Apple Inc registered in the U S and other countries...

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