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Earlens Photon Instructions Manual

Wireless earlens light-driven hearing aid
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Wireless Earlens Light-Driven Hearing Aid Hearing Professional Instructions
1.
Introduction ......................................................................................................... 2
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.
Wireless Connectivity- Made for iPhone Feature ........................................... 28
11.
Operating Specifications .................................................................................. 32
12.
Glossary of Terms ............................................................................................. 35
13.
Graphic Symbols Contained in Device Labeling ............................................ 35
14.
Laser Certification ............................................................................................. 36
IFU00022vJ
1

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  • Page 1: Table Of Contents

    Wireless Earlens Light-Driven Hearing Aid Hearing Professional 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

    1. Introduction CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. Rx ONLY For patient instructions, please see Earlens Light-Driven Hearing Aid Patient Instructions. For physician instructions, please see Earlens Light-Driven Hearing Aid Physician 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

    Note: Once the otologic and audiologic indications for use were met, approximately 95% of patients were successfully fit with the Earlens Hearing Aid (5% were unable to anatomically accommodate the Lens). IFU00022vJ...

  • 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 the 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.

  • 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 125Hz to 10,000Hz.
  • Page 8 FG Mode: Enables Functional Gain Mode and opens the sound field threshold entry (see page 22 for more information).  Import ELF files: Allows Earlens Customer Care to import ELF files from older versions of Earlens software.  Update Firmware: Initiates firmware updates for the Left or Right Processor when they are available.
  • Page 9 (Figure 11). Select to begin Measure Light Calibration Run Feedback Measurement View Earlens and/or conventional aided sound field thresholds 10 kHz threshold entry (blue box) Figure 11: Initial Fit screen...
  • Page 10 Fitting: Fine-tune the frequency response of the Processor (Figure 12), access automatic or manual acclimatization (Figure 13) and modify feature settings (Figure 14). Select and/or change program Change display (Output or Gain) Copy program Binaural programming link Increase or decrease gain Fitting Data Tab Acclimatization Figure 12: Fitting screen- Fine Tuning- Data Tab...
  • Page 11 Via drop down menu adjust noise reduction feature settings, directional microphone modes and feedback cancellation settings and streaming mic settings Figure 14: Fitting screen- Features User Controls: Set the user control configuration on the Processor, customize alert settings and enable Volume Learning (Figure 15). Figure 15: User Controls screen IFU00022vJ...
  • Page 12 Data Logging: View patient usage data (Figure 16). NOTE- “Read Processor” option must be selected to obtain data logging information. Figure 16. Data Logging screen Summary: View the summary of the fitting session, enter session notes, print Patient Instructions, and print Audiologist Report (Figure 17). Figure 17: Summary screen IFU00022vJ...
  • Page 13 • Processor Features in ELF Feature Description Options Background Noise Intended to reduce background noise Off, mild, moderate, strong Reduction without reducing speech levels. Impulse Noise Designed to reduce gain in the Off, On Reduction presence of sudden, loud noises. Wind Reduction Designed to reduce the noise Off, mild, moderate, strong...
  • Page 14 Obtain current audiometric threshold information for the patient. Though it is not required, we recommend obtaining thresholds at 125 and 10 kHz. • A quiet room is highly recommended for Earlens fittings especially for Light Calibration and feedback measurement. First Fit Steps The following instructions describe the steps necessary to complete a bilateral first fit of the Earlens Hearing Aid.
  • Page 15 b. A pop-window will appear asking “What would you like to do?” Select “Continue Session.” (Figure 20). Figure 20: What would you like to do? pop-up window NOTE- When “Read Processor” is selected, ELF will read the settings programmed to the Processor.
  • Page 16 5. Measure Feedback a. Prior to performing feedback measurement, ensure all noise sources in the fitting room are reduced. b. Select “Measure Feedback” in the Initial Fit screen. ELF will measure the maximum gain before feedback. Results can be viewed in the Tuning tab, in the Fitting screen, by selecting the Gain Display option (Figure 23).
  • Page 17 6. Fine Tuning Like any hearing instrument, the Earlens Hearing Aid can be customized to any patient’s needs. To change gain settings, click on individual band(s) or check the box next to the desired speech input curve to select all bands. Use the up or down arrow to increase or decrease gain settings in 1, 2 or 3 dB increments.
  • Page 18 Program Processors All changes made in the ELF software will temporarily be transmitted to the device. To permanently program the device, you must select “Program” in the ELF Status Bar or by following step 11. 11. Exit ELF When you “x” out of ELF or select File>Exit, a pop-up Window will appear asking you to “Save to Noah”...
  • Page 19 4. Go to the Features tab and select the patient preferred hearing aid microphone settings while streaming. Options include: On, -3, -6 (default), -9 and OFF. NOTE- via the Earlens Control app the user can adjust the hearing aid microphones to their preferred setting at any time.
  • Page 20 Figure 28: Data Logging Screen IFU00022vJ...
  • Page 21 Earlens System in response to soft inputs. This gain is representative of the gain applied at the compression threshold after fine-tuning to the needs of the patient.
  • Page 22 NOTE- You do not need to be actively connected to Processors to open FG Mode and enter threshold data. a. Open the FG Mode via Tools, in the Tool Bar. b. Manually enter aided audiometric threshold data (Figure 30). c. View data in Initial Fit screen, by clicking on “Show Aided Thresholds” (Figure 31). d.
  • Page 23 Figure 32: Patient Instruction print-out • Enable, Disable and Copy Program(s) Use the Programs menu to enable and disable different programs. The Main program represents the primary program and cannot be removed. The default program settings are 1.) Main, 2.) Music, 3.) Restaurant, 4.) Car.
  • Page 24 • Restore Defaults: Resets all features to recommended defaults. This feature can be located in the Fitting screen under the Features tab. Selecting “Restore Defaults” will not impact the fitting response of the Processors. 9.3. Removal and Replacement of the Light Tip from the Processor To remove the Light Tip from the Processor: a.
  • Page 25 Lens. The oil lubricates the eardrum to keep the Lens in place and functioning properly. Patients should only use the oil and container provided and/or recommended by Earlens. Instructions for Oiling Inform the patient about applying oil and describe the following steps: a.
  • Page 26 • Do not use any other Charger or AC wall adapter with the Earlens Hearing Aid, or use the Earlens Charger to charge any other devices. Using the incorrect Charger or AC wall adapter can damage the devices.
  • Page 27 We recommended using the Earlens Clinical Tools Troubleshooting Guide to troubleshoot any Earlens Hearing Aid issues. You can obtain this guide and the Light Pen and Simulator Instructions for Use by contacting Earlens Customer Care or by logging into your account at http://earlens.com/professional/...

  • Page 28: Wireless Connectivity- Made For Iphone Feature

    The Earlens Photon Hearing Aid features a wireless antenna that allows for direct connectivity to compatible Apple devices. This is an optional feature that you can offer to patients. 10.1 Device Compatibility The Earlens Photon Hearing is compatible with the following Apple devices that have iOS 9 or later. iPhone ®...
  • Page 29 3. Select the End icon to disconnect. 10.5 Earlens Control Mobile Application Download the Earlens Control App The user must have an iTunes account to download the Earlens Control mobile application. To set up an www.itunes.com account go to 1. Select the App Store icon on the Apple device.
  • Page 30 • Customize Sound with Bass and Treble Adjustments The user can adjust the master bass and treble settings in the EQ screen of the Earlens Control app to enhance listening in different environments or for audio streamed inputs. 1. Select EQ on the bottom navigation bar.
  • Page 31 Bluetooth status until connection is successful: 1. Turn the hearing aids OFF and then back ON. 2. Close the Earlens Control app by double-tapping the Home button and swiping up on the screen. Open the Earlens Control again.

  • Page 32: Operating Specifications

    11. Operating Specifications • Certain components of the Earlens Hearing Aid, including the Processor and the Light Tip are classified as a Type BF applied parts as described in the international standard IEC 60601- 1:2005, Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential Performance.
  • Page 33 The Earlens Hearing Aid has been successfully tested for use in the electromagnetic environment specified below. The customer or user of the Earlens Hearing Aid should ensure that it is used in such an environment, not to exceed conditions listed below.
  • Page 34 The Earlens Hearing Aid has been successfully tested for use in the electromagnetic environment specified below. The customer or user of the Earlens Hearing Aid should ensure that it is used in such an environment, not to exceed conditions listed below.

  • Page 35: Glossary Of Terms

    0.73 11.5. FCC Compliance • FCC ID: 2AGDU-EL1; IC ID: 20825-EL1 • The Earlens Light Driven Hearing Aid complies with part 18 of the FCC rules and ICES-003 of the IC rules. 12. Glossary of Terms Tympanic Membrane Lens Tympanic Lens...

  • Page 36: Laser Certification

    ©2017 Earlens Corp. All rights reserved. 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,...
  • Page 37 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. Apple, the logo, AirPlay, iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S. and other countries.

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