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Wireless Earlens Light-Driven Hearing Aid Physician Instructions
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
IFU00021vH
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Summary of Contents for Earlens Light Driven
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Page 1: Table Of Contents
Wireless Earlens Light-Driven Hearing Aid Physician Instructions Introduction ......................2 Wireless Earlens Light-Driven Hearing Aid Device Description ..... 2 Indications for Use ....................3 Fitting Range ....................... 3 Contraindications ....................3 Warnings ......................4 Precautions ......................4 Clinical Study Results ..................5 Operating Instructions .................. -
Page 2: Introduction
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. Rx ONLY For patient instructions, please see Earlens Light-Driven Hearing Aid Patient Instructions. For hearing professional instructions, please see Earlens Light-Driven Hearing Aid Hearing Professional Instructions. 2. Wireless Earlens Light-Driven Hearing Aid Device Description The wireless Earlens Light-Driven Hearing Aid uses non-visible light to send sound information to a customized Tympanic Lens (Lens). -
Page 3: Indications For Use
3. Indications for Use The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild to severe sensorineural hearing impairment who can benefit from amplification. -
Page 4: Warnings
• Do not crush, short circuit, modify or disassemble any component of the Earlens Hearing Aid. Keep all components of the Earlens Hearing Aid out of the reach of children, pets and others, to avoid risk of swallowing. •... -
Page 5: Clinical Study Results
125 Hz – 10,000 Hz. The prospective, single arm study assessed 48 subjects (96 ears) who wore the fully activated Earlens Hearing Aid in both ears in their daily lives for four months per study protocol. Safety and effectiveness were assessed during the four months. - Page 6 Northwestern Auditory Test No.6 (NU-6) test of word recognition with the Earlens Hearing Aid at a speech level of 45 dB HL. The objective was to show that the Earlens Hearing Aid provides a statistically significant improvement in mean aided word recognition at 30 days post placement when compared to the baseline unaided condition measured prior to placement.
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Page 7: Operating Instructions
Light Tip modification. One subject continues to report a sensation of fullness. Driven on the results of the Definitive study, the Earlens Hearing Aid has been shown to be safe and effective in delivering the full spectrum of amplification from 125 to 10,000Hz. - Page 8 The expected life for the Lens is one year. The Lens is expected to exhibit the same failure modes regardless of the duration of wear. The Lens can become displaced from the tympanic membrane, blocked by debris or degrade over time. This may cause the sound output of the Earlens Hearing Aid to IFU00021vH...
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Page 9: Operating Specifications
Lens Removal and Cleaning and Preparing Lens for Reinsertion instructions above. b. Verify functionality of the Lens on the patient’s ear using the Earlens Light Pen. Please read and follow the precautions and procedures found in the Earlens Light Pen Instructions for Use. If removal or reinsertion of the Lens is required, follow Lens Removal and Cleaning and Preparing Lens for Reinsertion instructions above. -
Page 10: Glossary Of Terms
* If the system is stored at a temperature outside the operating temperature range, allow the system to stabilize at room temperature for a minimum of 1 hour before use. 11. Glossary of Terms Tympanic Membrane Lens Tympanic Lens Earlens Fitting Software Electronic Article Surveillance Adverse Event 12. Graphic Symbols Contained in Device Labeling Symbol Description... -
Page 11: Laser Certification
Patent Protected/Pending: www.earlens.com/patents Earlens Photon and the Earlens Control app are compatible with the following Apple devices: iPhone 7 Plus, iPhone 7, iPhone SE, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPad Pro, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 4, iPad mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) using iOS 9 or later. - Page 12 Apple, the logo, AirPlay, iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. and other countries. IFU00021vH...