Starkey Pro Fit Software User Guide

June 10, 2024
Starkey

Starkey Pro Fit Software

Starkey-Pro-Fit-Software-PRODUCT

Pro Fit is a software medical device intended for hearing care professionals and designed to adjust air conduction hearing aids’ features and performance to compensate for a patient’s impaired hearing. It supports product families introduced in 2023 and beyond. This guide provides an overview of the Pro Fit fitting software, its system requirements, installation instructions, and regulatory information.

Intended Use

Pro Fit is intended for use in a clinical setting by hearing care professionals to adjust air conduction hearing aids’ features and performance.

System Requirements

Pro Fit fitting software requires a database application. It is recommended that you use NOAH 4 or our proprietary database called PatientBase. Compatible programmer options are listed on the System Requirements section of this document. For further information on NOAH application, please contact HIMSA. For additional information on PatientBase, please contact Customer Service.

Installation Instructions

  1.   Ensure that your computer meets the Pro Fit system requirements.
  2. Install the Pro Fit fitting software by following the on-screen instructions.
  3. Connect a programmer to your computer. Ensure that it is compatible with your system.
  4. Enter the patient-specific information into your database application and open Pro Fit.

Product Usage Instructions

Preparation

Before starting the fitting process, ensure that you have entered the patient- specific information into your database application and have opened Pro Fit.

Fitting

To adjust the air conduction hearing aid’s features and performance to compensate for a patient’s impaired hearing:

  1. Open Pro Fit and select Connect to begin a live session.
  2. On the Connect screen, select Product Simulator.
  3. Select the appropriate patient from the list displayed.
  4. Use the Fitting screen and its descriptions to adjust the hearing aid’s features and performance accurately.

Follow-up

After adjusting the air conduction hearing aid’s features and performance, follow up with the patient to ensure that they are comfortable with the settings and that they are working correctly.

Accessories

Pro Fit supports TeleHear, an accessory that allows you to remotely assist patients with their hearing aid settings. For more information, refer to the Pro Fit Overview section of this guide.

Troubleshooting

If you encounter any issues while using Pro Fit, refer to the Troubleshooting section of the user manual for assistance.

Regulatory Information

Refer to the Regulatory Information section of the user manual for detailed regulatory information on Pro Fit fitting software.

Supported products

  • Pro Fit fitting software supports product families introduced in 2023

Introduction/Intended Use

Introduction

The following guide provides information on Pro Fit fitting software. Pro Fit fitting software supports product families introduced in 2023 and forward. Product visibility in the Product Simulator screen varies by market.

Intended Use

Pro Fit is a software medical device intended to allow a hearing care professional to appropriately adjust an air conduction hearing aid’s features and performance to enable the hearing aid to compensate for a patient’s impaired hearing.

Intended User

  • Hearing care professional

Intended Environment

  • Clinical setting

Install

Install

Pro Fit fitting software is available in a variety of forms. Installation instructions are provided with each type of installation. We encourage you to work with your sales representative to establish a prosite account with us. This provides you a wide variety of information and gives you access to links for Pro Fit download. Once Pro Fit is installed, we provide automatic updates when future versions are released. We strongly encourage using that automatic feature to keep the software version up to date. Additionally, you may contact Customer Support for a USB or DVD copy.

System Requirements

System Requirements

  • Processor Speed: Intel i7 recommended
  • System RAM: 8 GB recommended
  • Operating System: Windows® 7, Windows 8 or 8.1, Windows 10, Windows 11
  • Hard Disk: Hard disk space required to run 4 GB
  • Browsers (for eStore Access, Pro Fit Updater, and TeleHear®):
    • Chrome™ – latest version
    • Firefox® – latest version
    • Microsoft Edge® – latest version
  • Communications Port for Programmer:
    • USB port for SpeedPort, SpeedPort 2, NOAHlink, HiPRO USB, 2.4 GHz wireless programmer and NOAHlink wireless programmer
  • Audio Hardware: Sound card and stereo speakers are recommended to take full advantage of media sounds
  • Client Database: NOAH 4, PatientBase
  • Optional tools
    • NOAH 4 software or PatientBase software
    • Internet connection
    • Real ear measurement system
    • Adobe™ Acrobat Reader™

Database options

Pro Fit fitting software requires a database application. We recommend using NOAH 4 or our proprietary database called PatientBase. For further information on the NOAH application, please contact HIMSA. For additional information on PatientBase, please contact Customer Service.

Pro Fit Overview

Pro Fit Overview

This guide provides an overview of the Pro Fit fitting software. The high- level information in this guide covers general navigation, functionality and tools. For additional information with greater detail, please go to the Help menu and click on Help for Pro Fit. The Connect screen is the opening screen and the launch pad for all Pro Fit functions. Features include:

  • Retrieve Session
    • Open past, saved sessions to view or to push into connected hearing aids.
  • Product Simulator
    • Review software tools and features without connecting to live devices. Most features are available and show their default settings.
  • Hearing Loss Simulator
    • The Hearing Loss Simulator is a tool to demonstrate the effects of the patient’s hearing loss using a variety of sounds. Various display options, visual aids, and drawing tools help facilitate the discussion of the impact of hearing loss.

Additionally, hyperlinks located at the top right side of the screen:

  • Resources
  • Ordering
  • Service
  • TeleHear

Select Connect to begin a live session or choose Product Simulator.

Navigation

Once a fitting session has started, either by connecting to hearing aids or by Product Simulator, all fitting screens are available. We recommend using the session type organization for quick access to the most commonly used screens in each session type. Additional fitting screens are ordered by usage and are available by clicking on the three bars (also called a hamburger icon) at the top of the colored bar on the left side of the
fitting session.

Pro Fit is organized into three session types: Preparation, Fitting, and Follow-Up. Pro Fit automatically advances through the session types. You may also change between session types if desired.

  • Preparation
    • Preparation is a session type for preparing hearing aids before the patient arrives. The most common preparation screens, Experience, Programs, User Controls, and Accessories, are accessible at the top of the screen. When reading new hearing aids, Preparation is the first session type displayed in Pro Fit.
  • Fitting
    • Fitting is a session type for the first session with the patient. Fitting offers easy access to: Feedback Canceller, Quick Fit, User Controls, and Indicators. Upon reading hearing aids the second time, Pro Fit displays the Fitting session type.
  • Follow-up
    • The Follow-up session type is the default for all sessions after the initial fitting. The most commonly used adjustments are accessible at the top of the screen: Data Log, Fine Tuning, Indicators, User Controls.

Fitting screen descriptions

  • Quick Fit – provides convenient accessibility to adjust overall gain, overall output, low frequency gain, high frequency gain, and occlusion.

  • Fine Tuning makes discreet, frequency-specific adjustments to channel gains and maximum output. Channel adjustments change gain and compression settings and MPO modifies the maximum output. Adjustments can be made to each individual channel, to groups of channels labeled low frequencies, mid frequencies, high frequencies, or ultra frequencies, or to all channels simultaneously. Adjustments vary by product.

  • Feedback Canceller – adaptive, active feedback cancellation prevents most feedback. For optimal performance, the feedback canceller should be calibrated in the patient’s ear. Click on Begin to present the calibration signal in both ears.

  • User Controls – tailor the hearing aid controls to the specific needs of each patient. Click on a type of control (i.e., volume) and drag to a gesture and side (i.e., short press – right). Additional user control adjustments include volume and tinnitus range and step size.

  • Experience – transition patients with varying levels of hearing aid experience from initial, spontaneously accepted gain settings to the final, desired, target-gain settings. Available as a manual or automatic feature.

  • Programs – configure phone and loop options as well as copy and move programs. The programs bar, located in the center of most screens, provides easy access to selecting program environments based on your patient’s need. Additionally, selecting a program environment automatically enables the corresponding speech indicator for that memory.

  • Indicators – a wide variety of indicator options includes language and gender for speech indicators as well as many frequency-specific tone indicators. Levels may be set globally or individually for speech and/or tone indicators. Indicators may be played through the hearing aid for counseling through desktop speakers.

  • Sound Manager – comprised of noise management, adaptive algorithms, and directionality adjustments. The default view shows settings across all enabled programs. Adjustments can be made by clicking the up/down arrows on the setting value or by clicking details for more information.

  • Data Log – collects and summarizes hearing aid data. View global averages or drill into memory-specific data. Data Log is a valuable tool for counseling and targeting specific hearing aid adjustments.

  • Accessories – pair hearing aids to accessories (2.4 GHz accessories may be paired outside of Pro Fit as well) and adjust the level of the hearing aid microphone while streaming. Add a treble boost or bass boost to the stream by selecting a streaming sound option.

  • Frequency Lowering – a proprietary algorithm that characterizes the high-frequency spectral shape and dynamically recreates that spectral shape inside a lower frequency target region. Adjustments include the bandwidth and gain.

  • Tinnitus – access to enable the tinnitus stimulus and set modulation as desired. Stimulus Personalization guides you through testing for the minimum detection levels and minimum masking levels to customize the tinnitus stimulus to your patient’s specific needs. Availability varies by product.

  • Speech Mapping – offers the ability to view and capture inputs in real time. This information is often used for counseling or demonstrating the benefits of amplification. Speech Mapping
    is only available during a live fitting.

  • Self Check – performs a diagnostic test of the components in your patient’s wireless hearing aids. The diagnostic test can be initiated via Pro Fit or the mobile application.

  • Hearing Aid Test – a tool that measures the hearing aid’s performance.

  • Audiometer – a tool for conducting in-situ threshold testing through the hearing aids. In-situ Audiometry does not replace conventional diagnostic audiometry.

  • Verify Comfort – confirms that loud and soft inputs sound satisfactory to the patient by presenting a sequence of tones across the frequency response curve.

  • TeleHear – A tool that allows you to make remote adjustments to your patient’s hearing aid settings. The TeleHear portal tracks your patients’ call history, and manages your office and users’ details for remote programming.

Additional screens accessible from the left navigation bar are:

  • Troubleshooting – a tool used to address patient complaints and provide solutions. Issues can be resolved by applying these solutions directly to the hearing aid(s).
  • Audiology On Demand – a live remote-assistance tool that allows Customer Service representatives to provide assistance by chatting and/or viewing your desktop and sharing control of your mouse and keyboard. This feature is only available if the PC has Internet access.
  • Fitting Summary – provides a quick visual overview of the hearing aid’s features and setting information including programs, noise control, indicators, status, etc. for a particular live or simulated fitting.
  • Save and End Session – Click to save then end the session and return to the Connect screen. Alternately, clicking on the black ‘X’ in the upper right corner prompts a session save dialog then closes Pro Fit.

Top Navigation

The top, horizontal tool bar of Pro Fit includes six menus:

  • File – offers typical selection menu: open, save, print, and close
  • Edit – Undo, redo and copy settings
  • Preferences – a wide variety of customization options for a personalized fitting experience
  • Tools – various options most often used during fittings. Most are an additional access point
  • Display – select from various display and input options.
    • Default: Speech input and predicted real ear response
  • Help – this menu comprises help files, specific version number, the EULA, and other help-related items

The secondary tool bar offers quick access to many items that are under the upper tool bar menus. The fitting formula dropdown is conveniently located on this tool bar providing a visual indication of the selected fitting formula.

Setup

Setup

  1. Install Pro Fit fitting software. A series of screens assists you in setting up the software for your region.
  2. Connect a programmer to your computer. Compatible options are listed in the System Requirements section of this document.
  3. Enter the patient-specific information into your database application and open Pro Fit.
  4. Connect the hearing aids to the programmer using the appropriate programmer and connection (i.e., wired or wireless) defined in Cables and Connectors under the Help menu.
  5. Select the hearing aids by clicking on the hearing aid card. A blue bar at the top of the card indicates that the hearing aid is selected. Once the aids are selected, click Connect.

Fitting Session with Pro Fit

  • After completing the setup process and connecting, the new aids are now at the optimal setting with all features at default. Configure user controls and programs as desired. We recommend that you always run the feedback canceller test with the hearing aids in the ears.
  • Upon completion of the fitting session, click on the X in the upper right corner to save and exit. Saving the session stores that session in the database for future retrieval if needed.

Safety Information

We are required by regulations to provide the following warnings:

WARNING: For safety and correct usage, we recommend that you familiarize yourself with the fitting software. Additional resources such as detailed fitting guides and online courses are available on the prosite. Take special care when setting up the tinnitus stimulus, ensuring that the stimulus level does not exceed a comfortable level for the patient. Use precaution when fitting a power instrument where the maximum sound pressure capability exceeds 132 dB SPL as you may risk causing damage to the hearing of that patient. Please follow instructions to remove hearing aids from the patient’s ear for certain procedures such as updating firmware.

Clinical Benefit

  • Pro Fit alone does not provide a direct clinical benefit. An indirect clinical benefit is provided by enabling the hearing aids to achieve their intended purpose.

Security Notice

Patient data is private and protection of it is important, therefore please refer to the following:

  • Compliance with any and all applicable privacy data and security laws.
  • Obtain any required patient authorizations or consents, and provide all necessary and applicable privacy notices to patients when using software.
  • Take all reasonable precautions from malicious software by securing your computer systems with up to date antivirus software, install Windows security updates, and activate firewalls.
  • Maintain administrative, technical, and physical measures required to maintain appropriate information security with respect to protected health information and compliance with HIPAA and any
  • other applicable privacy and data security laws.

Please note that this is not an exhaustive list.

Regulatory information

Starkey Laboratories, Inc.

  • 6700 Washington Ave. South Eden Prairie, MN 55344 USA

  • Starkey Laboratories (Germany) GmbH

  • Weg beim Jäger 218-222 22335 Hamburg Germany

  • Waste from electronic equipment must be handled according to local regulations

  • Consult user manual

  • Medical Device

Regulatory information

Starkey-Pro-Fit-Software-FIG-4

Pro Fit is a trademark of Starkey Laboratories, Inc.

©2023 Starkey Laboratories, Inc. All Rights Reserved. 3/23 BKLT3161-02-EN-XX
Patent: www.starkey.com/patents

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