(147 days)
Not Found
Not Found
No
The summary describes user-adjustable parameters and a self-fitting method based on dynamic range compression (DRC), but there is no mention of AI or ML algorithms being used for sound processing, fitting, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is intended to amplify sound for individuals with perceived mild to moderate hearing impairment, which addresses a health-related condition.
No
The Bose Hearing Aid is intended to amplify sound for individuals with perceived hearing impairment, allowing users to adjust it themselves without a hearing test or professional assistance. Its purpose is to compensate for hearing loss, not to diagnose a medical condition.
No
The device description explicitly states it incorporates microphones on the earbuds for audio input and has an on-device user control (in-line remote), indicating it includes hardware components beyond just software.
Based on the provided information, the Bose Hearing Aid is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment." This describes a device that modifies sound for a user, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a hearing aid that uses microphones, Bluetooth, and a mobile app to adjust sound amplification. This aligns with the function of a hearing aid, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory tests
The studies described focus on the performance and usability of the hearing aid in amplifying sound and being self-fitted, which are relevant to a hearing aid but not an IVD.
N/A
Intended Use / Indications for Use
The Bose Hearing Aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Product codes (comma separated list FDA assigned to the subject device)
QDD
Device Description
The Bose® Hearing Aid is a user-fitted wireless air-conduction hearing aid intended for use by individuals 18 years of age and older with perceived hearing impairment. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth® using a handheld device (iOS or Android) through the Bose Hear mobile app. There is an on-device user control (in-line remote) on the right cable (attached to neckband) that allows separate control of hearing aid ("world") volume and streaming audio volume, as well as control of directional hearing aid mode. In addition to hearing aid functionality for environmental listening, the Bose Hearing Aid can be used for placing and receiving telephone calls and for streaming audio from a Bluetooth compliant mobile device that has been paired with the Bose Hearing Aid. The controls accessible through the Bose Hear mobile application and on the hearing aid are used by the user to configure parameters, settings, and listening modes.
The Bose Hearing Aid (Figure 1) consists of a flexible neckband housing a rechargeable lithium ion battery and electronic components with extending cables for the right and left ears. The system also includes a 5 Volt USB AC to DC Power supply wall charger with an attaching USB cable (not shown). Earbuds are connected to the neckband by flexible wires and on each earbud is mounted a Bose StayHear+ eartip; three sizes of tips are packaged with the product so that the user can choose the optimal size.
The Bose Hearing Aid is self-fitted by the user by adjustment of the level (World Volume) and spectral tilt (Treble/Bass) settings. The hearing aid has four (two per earbud) microphones that may be configured in omnidirectional or directional modes during use. The Bose Hear mobile application gives the wearer access to all gain settings (e.g. World Volume and Treble/Bass) and device configurations while the in-line remote buttons (Figure 1) can be used to adjust the World Volume and directional mode. These settings are preserved between use sessions and the settings from the previous use session are recalled upon power up of the device. The Bose Hearing Aid has Active Noise Reduction (ANR), which is established using feedback and feedforward control loops to reduce environmental sounds. The Bose Hearing Aid is powered by a rechargeable 3.7 V, 250 mAh Liion battery pack and is recharged using a 5 Volt USB AC to DC power supply wall charger provided with the hearing aid. Hearing aid signal processing includes 12-channel wide dynamic range compression amplification with compression threshold fixed at speech-equivalent 52 decibels (dB) sound pressure level (SPL). The Bose Hearing Aid includes Active Noise Reduction (ANR) to reduce environmental noise and to decrease amplification of the user's own voice typical of an occluding earbud. ANR is continuously active, even when the Bose Hearing Aid is used as a hearing aid.
Additional features include:
- Feedback cancellation
- Steady state noise reduction
- Directionality (three modes controllable by user)
- Impulse noise control
- Left/Right balance
- Bluetooth compliant 2.4 GHz wireless radio for streaming audio, telephony, and control
- Microphone array for telephony
- Volume-optimized audio equalization (selectable high-frequency boost when listening to streamed content)
- Voice prompts
- Battery life of approximately 10 hours
- NFC pairing for compatible Android devices
The Bose Hear mobile application is designed to function with a user's compatible personal smartphone or tablet device. It is available free for download on iOS or Android based systems. The Bose Hear mobile application (Bose Hear App) is used to set gain parameters as well as device settings on the Bose Hearing Aid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Direct-to-consumer sale and use without the assistance of a hearing care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies (Phase I and Phase II) and a human factors study were conducted to validate the self-fitting methodology for the Bose Hearing Aid.
Phase I Study: Laboratory Evaluation of Validity of Bose Self-Fitting Method
- Study Type: Laboratory study with a simulated hearing aid
- Sample Size: Fifty adult subjects (49 with mild to severe hearing loss, 1 with normal hearing)
- Key Results:
- The Bose self-fitting method is reliable; average test-retest error was 3.9 dB (within 4 dB test-retest reliability of probe microphone measurements).
- The Bose self-fitting method is valid; average deviation from NAL-NL2 prescribed gain for subject-selected gain was 5 dB (in line with published reports of preferred gain settings after post-fitting fine tuning).
- Sound quality provided by the Bose self-fitting method is sufficient; prescribed parameters were not significantly more preferred than subject-selected ones.
- Overall, the Phase I study provides evidence that the Bose Self-Fitting method results in outcomes not inferior to professional fitting for adults with mild to moderate hearing loss.
Phase II Study: Clinical Validation of Bose Self-Fitting Method
- Study Type: Prospective, two-arm, pre-market study
- Sample Size: 75 adult subjects with mild to moderately severe hearing loss. Pro-Fit Group: 37, Self-Fit Group: 38.
- Overall Study Design: Subjects participated in three clinic visits (First Fit, Fine-Tuning, Assessment) and several weeks of field use. Subjects were initially professionally fit and then assigned to either a "Pro-Fit" Group (audiologist fit only) or a "Self-Fit" Group (self-fit via Bose Hear mobile app implementing DRCs).
- Safety Results: No AEs or SAEs occurred for any subject over the course of the study.
- Effectiveness Results:
- Primary Endpoint: Comparison of prescribed hearing aid settings versus DRC user-selected settings with respect to sound quality.
- Subjects in the Self-Fit Group preferred their own settings to the professionally-selected settings significantly (p
- Primary Endpoint: Comparison of prescribed hearing aid settings versus DRC user-selected settings with respect to sound quality.
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
DE NOVO CLASSIFICATION REQUEST FOR BOSE® HEARING AID
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Self-fitting air-conduction hearing aid. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.
NEW REGULATION NUMBER: 21 CFR 874.3325
CLASSIFICATION: Class II
PRODUCT CODE: QDD
BACKGROUND
DEVICE NAME: Bose® Hearing Aid
SUBMISSION NUMBER: DEN180026
DATE OF DE NOVO: May 11, 2018
CONTACT: Bose Corporation The Mountain Framingham, MA 01701
INDICATIONS FOR USE
The Bose Hearing Aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
LIMITATIONS
The Bose Hearing Aid is subject to labeling and conditions for sale requirements under 21 CFR 801.420 and 801.421.
Limitations on device use are included in the Instructions for Use as "Important Information" and "Warnings, Precautions, and Safety Considerations."
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Important Information from the Instructions for Use:
This product may help you hear better if you:
- . strain to follow conversations when others don't, especially in noisy places.
- have trouble understanding the TV or telephone calls. ●
This product may not be right for you if you:
- Consistently experience feedback (whistling) of the earbuds when you turn up . World Volume to a level that is comfortable for you, even after you have followed the suggestions in the Instructions for Use to make sure your eartips fit properly.
- Feel the hearing aid is not providing enough amplification even at the highest . World Volume setting.
A hearing health care professional may be able to help you select a different hearing aid solution to meet your needs.
You should see a hearing health care professional if you:
- . Have a visible deformity of the ear.
- . Have a current ear infection or a history of active discharge from one or both ears within the past 90 days.
- . Have sudden or rapid progression of hearing loss within the past 90 days in one or both ears.
- Have acute or chronic dizziness, poor dexterity, poor vision, or significant . dementia.
- . Suspect that you have significant ear wax accumulation or a foreign object in the ear canal. Symptoms of significant ear wax accumulation can include itching in your ear, a feeling of fullness in your ear, and/or reduced hearing.
- Experience pain or discomfort in the ear.
- . Have a noticeable difference in hearing between ears.
- Have sudden onset or rapid worsening of tinnitus (ringing in the ear) in one or ● both ears within the past 90 days.
It is good health practice for a person with a hearing loss to have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear). Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS AND PRECAUTIONS.
2
DEVICE DESCRIPTION
The Bose® Hearing Aid is a user-fitted wireless air-conduction hearing aid intended for use by individuals 18 years of age and older with perceived hearing impairment. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth® using a handheld device (iOS or Android) through the Bose Hear mobile app. There is an on-device user control (in-line remote) on the right cable (attached to neckband) that allows separate control of hearing aid ("world") volume and streaming audio volume, as well as control of directional hearing aid mode. In addition to hearing aid functionality for environmental listening, the Bose Hearing Aid can be used for placing and receiving telephone calls and for streaming audio from a Bluetooth compliant mobile device that has been paired with the Bose Hearing Aid. The controls accessible through the Bose Hear mobile application and on the hearing aid are used by the user to configure parameters, settings, and listening modes.
Hearing Aid System Components
The Bose Hearing Aid (Figure 1) consists of a flexible neckband housing a rechargeable lithium ion battery and electronic components with extending cables for the right and left ears. The system also includes a 5 Volt USB AC to DC Power supply wall charger with an attaching USB cable (not shown).
Image /page/2/Figure/4 description: This image shows a diagram of wireless earbuds with a neckband. The diagram labels the different parts of the earbuds, including the earbuds themselves, the in-line remote, and the neckband. Other labeled parts include the StayHear+ tip, NFC pairing touchpoint, volume up/down buttons, multi-function button, USB connector, power/bluetooth button, and battery/bluetooth indicators.
Image /page/2/Figure/5 description: The image shows the text "Figure 1. Bose Hearing Aid System". The text is in bold font. The figure number is 1.
Earbuds are connected to the neckband by flexible wires and on each earbud is mounted a Bose StayHear+ eartip; three sizes of tips are packaged with the product so that the user can choose the optimal size.
3
The Bose Hearing Aid is self-fitted by the user by adjustment of the level (World Volume) and spectral tilt (Treble/Bass) settings. The hearing aid has four (two per earbud) microphones that may be configured in omnidirectional or directional modes during use. The Bose Hear mobile application gives the wearer access to all gain settings (e.g. World Volume and Treble/Bass) and device configurations while the in-line remote buttons (Figure 1) can be used to adjust the World Volume and directional mode.
These settings are preserved between use sessions and the settings from the previous use session are recalled upon power up of the device. The Bose Hearing Aid has Active Noise Reduction (ANR), which is established using feedback and feedforward control loops to reduce environmental sounds. The Bose Hearing Aid is powered by a rechargeable 3.7 V, 250 mAh Liion battery pack and is recharged using a 5 Volt USB AC to DC power supply wall charger provided with the hearing aid.
Hearing Aid Features
Hearing aid signal processing includes 12-channel wide dynamic range compression amplification with compression threshold fixed at speech-equivalent 52 decibels (dB) sound pressure level (SPL). The Bose Hearing Aid includes Active Noise Reduction (ANR) to reduce environmental noise and to decrease amplification of the user's own voice typical of an occluding earbud. ANR is continuously active, even when the Bose Hearing Aid is used as a hearing aid.
Additional features include:
- Feedback cancellation
- Steady state noise reduction
- · Directionality (three modes controllable by user)
- Impulse noise control
- · Left/Right balance
- · Bluetooth compliant 2.4 GHz wireless radio for streaming audio, telephony, and control
- Microphone array for telephony
- · Volume-optimized audio equalization (selectable high-frequency boost when listening to streamed content)
- · Voice prompts
- · Battery life of approximately 10 hours
- · NFC pairing for compatible Android devices
Hearing Aid User Interface
The Bose Hear mobile application is designed to function with a user's compatible personal smartphone or tablet device. It is available free for download on iOS or Android based systems. The Bose Hear mobile application (Bose Hear App) is used to set gain parameters as well as device settings on the Bose Hearing Aid.
4
Image /page/4/Figure/0 description: The image shows a smartphone screen displaying the settings for Bose headphones. The screen features controls for world volume and tone correction, with the world volume set to 15 and tone correction set to 29. Other elements include a battery indicator, menu, quick save options, mute button, and drawers for ear balance, directivity, and modes.
Figure 2. Bose Hear Mobile App home screen
· MODES
Allows the user to save and name settings that he/she has identified for different use cases or use environments (Figure 2).
· WORLD VOLUME CONTROL WHEEL
Controls gain and compression parameters in 12 channels of wide dynamic range compressive hearing aid signal processing. As the user adjusts from zero to top of control, positions correspond to prescriptive fittings for hearing losses up to moderate hearing loss. The user can manipulate the wheel to arrive at the optimal setting for his/her hearing status, which will be the one that provides greatest perceived benefit and comfort.
· TONE CORRECTION CONTROL WHEEL
Controls spectrum balance. This is used to balance low and high frequency sound to suit the user's sound quality preferences.
· EAR BALANCE
Allows user to balance volume across ears (Figure 3a).
· DIRECTIVITY
Allows user to select from three modes that provide three levels of focus on sounds in front of the user: no emphasis (Everywhere), moderate emphasis (Front), and maximum emphasis (Focused). When attempting to converse with a person in front of the user in a noisy
5
environment, the user will experience maximum benefit when directional control is set to maximum emphasis (Figure 3b).
Image /page/5/Picture/1 description: The image shows a smartphone screen displaying a balance adjustment interface. The screen indicates that the right ear volume is louder, with a numerical value of 8 displayed prominently. Options to mute either the left or right ear are available at the bottom of the screen.
Figure 3a. Balance Screen
Figure 3b. Directivity Screen
Image /page/5/Picture/4 description: The image shows a mobile phone displaying a screen with the title "DIRECTIVITY". Below the title, there are three circular icons with eye symbols inside. The first icon is labeled "FOCUSED", the second is labeled "FRONT", and the third is labeled "EVERYWHERE". The "FRONT" icon has a gold outline, indicating that it is currently selected.
A subset of Bose Hearing Aid functions can be controlled by buttons on the device. The buttons in-line with the right cable control the following functions:
- World Volume up & down
- · Change directivity modes (by simultaneously pressing both World Volume buttons)
- Streamed volume up & down
- Control of telephone and streamed sources
The power/pairing button is located on the underside of the neckband, and performs the following functions:
- Power on
- Power off
- · Initiate Bluetooth pairing
- Clear the Bluetooth pairing list
- Announce connection state while on
Two LED indicator lights on the inside of the neckband provide visual status of the Bluetooth connection and battery status. Optional voice prompts also provide redundant audio feedback through the earbuds related to pairing and battery status.
6
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical/bench studies conducted on the Bose Hearing Aid to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized in the following table and sections below.
| Test Standard/ Method | Test Purpose/
Description | Components Tested | Acceptance
Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------|
| • Overvoltage Protection
Circuit
• Near field
Communication
• Battery life assessment
per ANSI/CTA 2051 | Electrical
Testing | Bose Hearing Aid,
StayHear + medium
size tip + USB Power
Supply | See below | Passed |
| • IEC 60601-
1:2005+A1:2012
• IEC 60601-2-66:2015
• IEC 62133:2012, Ed. 2. | Electrical and
Battery Safety | “ | As defined in the
listed standards
(details below) | Passed |
| • IEC 60601-1-2:2014 | Electromagnetic
Compatibility
(EMC) | “ | As defined in the
listed standard | Passed |
| • AAMI TIR 69:
2017 | Wireless
coexistence risk
assessment | “ | As defined in the
listed standard | Reported |
| • Eartip fit analysis
• Neckband fit
verification | Mechanical | “ | See below | Accepted / Passed |
| • ANSI/CTA 2051
• ANSI/ASA S3.22 | Electroacoustic | “ | Various requirement
as defined in the
listed standards
(details below | Passed or
Reported |
| • Bose-specified
procedure, 'Medical -
Usability Engineering
Procedure' specifies
requirements to
analyze, design, verify
and validate usability
• IEC 60601-1-6:
2010+A1:2013 | Usability
Engineering | “ | Per the requirement
of the listed protocol
and standard | Passed |
| • 10993-1:2009/TC 1
2010 Assessment
• Cytotoxicity, Irritation,
Skin Sensitization tests
(standards/details
below) | Biocompatibility | Bose Hearing Aid,
StayHear + medium
size tip | Per the requirement
of the referenced
standard (details
below) | Passed |
| • IEC
62304:2006+A1:2015 | Software | Bose Hearing Aid,
StayHear + medium
size tip + USB Power
Supply + Mobile
Apps (iOS and
Android) | As defined in the
listed standard | Passed |
| Table 1. Bose Hearing Aid Test Summary Table |
|---|
7
ELECTRICAL AND BATTERY SAFETY, ELECTROMAGNETIC COMPATIBILITY & WIRELESS COEXISTENCE/SAFETY
Verification for electrical overvoltage protection circuit verification and wireless technology is summarized in the following table:
| Test
Standard/
Method | Test Purpose/
Description | Component (s)
Tested | Acceptance Criteria | Results |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Overvoltage
Protection
Circuit
Verification | To demonstrate
that Bose Hearing
Aid device
charging
subsystem is
protected from
application of
excessive input
voltage. | Bose Hearing
Aid, StayHear+
medium size tip
- USB Power
Supply | • Within the permissible operating voltage range the device shall draw 127 mA ± 20 mA of current, which indicates proper charging of the rechargeable battery.
• Device shall continue to charge down to 4.4 V.
• Device shall continue to charge up to at least 6.8 V and no higher than 8.45 V.
• Beyond the upper limit for the operating voltage range the device shall draw no more than 2.5 mA from the power supply, indicating proper function of the protection circuitry. | Pass |
| Wireless
Technology
Verification | To demonstrate
that Bose Hearing
Aid device
initiates Bluetooth
pairing, and
Bluetooth control
and streaming
functionality. | Bose Hearing
Aid, StayHear +
medium size tip - USB Power
Supply | • Pairing, control, streaming verification with the paired mobile device. | Pass |
| Table 2. Electrical Testing and Wireless Technology Evaluation | |||
|---|---|---|---|
In addition, as summarized above, electrical safety, battery safety, and electromagnetic compatibility (EMC) testing was conducted on the Bose Hearing Aid to verify that the device meets the requirements for basic safety and essential performance per the following international standards:
- . IEC 60601-1:2005 (Ed. 3) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint). Medical electrical equipment – Part 1: General requirements for basic safety and essential performance - Edition 3.1
- IEC 60601-2-66:2015. Medical electrical equipment: Practical requirements for basic . safety and essential performance of Hearing Instruments and Hearing Instrument Systems
- IEC 62133:2012, Ed. 2. Medical electrical equipment: General requirements on basic ● safety and essential performance of Rechargeable Cells & Lithium Ion or Nickel
8
Battery used in portable devices
- . IEC 60601-1-2, Ed. 4, 2014. Medical electrical equipment: General requirements on basic safety and essential performance on Electromagnetic Compatibility.
The range of testing and all acceptance criteria are appropriate to evaluate this device based on its proposed intended use. All acceptance criteria were met.
A risk analysis was also conducted for wireless coexistence testing per AAMI TIR 69, 2017, Risk management of radio-frequency wireless coexistence for medical devices and systems. The Bose BMD-001 Hearing Aid uses standard 2.4GHz Classic Bluetooth and Bluetooth Low Energy (BLE) standards to communicate between the hearing aid and the user's Bluetooth enabled device. From the risk assessment, the temporary loss of Bluetooth communication from interfering RF signals is appropriately considered a negligible risk and according to AAMI TIR 69, wireless coexistence testing is not required. Note that the interruption of device control from the App would be similar to when the user is separated from their Bluetooth enabled device.
The Bose Hearing Aid contains a Bluetooth radio transmitter operating in the ISM band (2.400 to 2.4835 GHz) at less than 10 mW EIRP. The output power level at these operating frequencies of the Bose Hearing Aid was deemed sufficiently safe in terms of human exposure to nonionizing radiation for the intended use.
MECHANICAL PERFORMANCE
The Bose Hearing Aid device mechanical design was verified as summarized in the following table:
| Test
Standard/Method | Test Purpose/ Description | Component (s)
Tested | Acceptance
Criteria | Results |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Eartip Analysis -
Previous
Commercial Use | Memo concerning
validation of StayHear+tips
fit comfort, and
conformance to IEC 60601-
2-66 | Bose Hearing
Aid, StayHear+
tips | N/A | N/A |
| Neckband Fit
Verification | To demonstrate that Bose
Hearing Aid device is
designed and manufactured
to meet range of user
anatomy (neckband opening
and cord length) in
accordance with 1988
Anthropometric Survey. | Bose Hearing
Aid, StayHear +
medium size tip
- USB Power
Supply | Meet neckband
opening and
cord length
design to
accommodate
the 5th to 95th
percentile range
of user
anatomy | All
requirements
and expected
measurements
were within
specified
range. |
Table 3. Mechanical Performance Testing
The range of testing and all acceptance criteria are appropriate to evaluate this device based on its proposed intended use. All acceptance criteria were met.
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ELECTROACOUSTIC PERFORMANCE
Electroacoustic testing with measurements and associated acceptance criteria at the system-level was performed on the Bose Hearing Aid as summarized in the Tables as follow, including per the applicable standards of ANSI S3.22-2009 and ANSI/CTA 2051-2017.
| Applicable Standards:
ANSI CTA 2051:2017 (Clause)
ANSI ASA S3.22:2009 (Clause) | Test | Acceptance Criteria | Result
(Pass/Fail/
Complete) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------|------------------------------------|
| CTA 2051 (4:1)
Custom corrections for device may be
used if CORFIG in standard is invalid | Custom Coupler
Response for Flat
Insertion Gain
(CORFIG) | N/A* | Complete |
| CTA 2051 (4.1)
Use Bose custom CORFIG for Bose
Hearing Aid | Frequency Response
Bandwidth | At least 250 Hz – 5 kHz** | Pass |
| ANSI S3.22 (6.2) | Maximum Acoustic
Output | Less than or equal to 120 dB
SPL** | Pass |
| ANSI S3.22 (6.11) | Output Distortion | Less than or equal to 5%** | Pass |
| CTA 2051 (4.4.2)
Test frequency = 500 Hz
Test input level = 100 dB SPL
Gain adjusted for output = 80 dB SPL
or, if not possible, for 100 dB SPL | Input Distortion | Less than or equal to 5%** | Pass |
| ANSI S3.22 (6.12) | EIN | Less than or equal to 32 dB
SPL** | Pass |
| CTA 2051 (4.8) | Latency | Less than or equal to 15 ms** | Pass |
| CTA 2051 (4.7) | Estimated Battery
Life | N/A* | Complete |
| ANSI S3.22 (6.3) | HFA-OSPL90 | N/A* | Complete |
| ANSI S3.22 (6.5) | HFA-FOG | N/A* | Complete |
| ANSI S3.22 (6.7) | RTG | N/A* | Complete |
| CTA 2051 (4.10 – 4.17) | Reporting of Hearing
Aid Features | N/A * | Complete |
| Fixed or Level Dependent Frequency
Equalization - Tone Control
Level Dependent Gain/Compression
SNR Enhancement
Noise Reduction
Feedback Control / Cancellation
Personalization
Device Coupling to the Ear
Wireless Connectivity | | | |
| N/A | Serial Number and
Firmware are
recorded | N/A* | Complete |
Table 4. Electroacoustic Performance Requirements for Bose Hearing Aid
- Acceptance criteria = N/A indicates reporting requirement, but not performance requirement
**As specified in applicable clause of CTA 2051
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| Test
Standard/
Method | Test Purpose/
Description | Component (s)
Tested | Acceptance Criteria | Results |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Monaural /
Binaural
Directionality
Verification | To demonstrate that
Bose Hearing Aid
device selects between
Binaural and
Monaural
Directionality
depending on the | Bose Hearing
Aid, StayHear +
medium size tip
- USB Power
Supply | • Room sound audible in both ears.
• Scratching sound present in left ear.
• Scratching sound present in right ear.
• Silence in right ear and room sound in left ear.
• Room sound only in left ear, no scratching.
• Silence in left ear and room sound in right ear.
• Room sound only in right ear, no scratching. | All
Passed |
The range of testing and all acceptance criteria are appropriate to evaluate this device based on its proposed intended use. All acceptance criteria were met.
USABILITY ENGINEERING
Requirements to analyze, design, verify and validate usability of the Bose Hearing Aid were developed and implemented to ensure that risks resulting from normal use and use errors are assessed and mitigated. This was formally evaluated in a Human Factors Study (please refer to Human Factors Testing section below for details).
In addition, The Bose Hearing Aid met the applicable requirements in IEC 60601-1-6:2010+A1:2013. Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability - Edition 3.1 : Consolidated Reprint.
BIOCOMPATIBILITY
The Bose Hearing Aid was tested in accordance with ISO 10993-1, FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process", and the Bose risk management process.
The following table summarizes the testing results which indicate that the materials used in the device are safe for their intended use:
| Component
| Tested | Test Requirement | Test Results |
|---|---|---|
| Bose Hearing | ||
| Aid | MEM elution | |
| Cytotoxicity per ISO | ||
| 10993-5 | Pass (Grade 0) - no evidence of causing cell lysis or | |
| toxicity | ||
| Tests for irritation per | ||
| ISO 10993-10 | Pass (test score was 0.0 and 0.1) | |
| Tests skin sensitization | ||
| per ISO 10993-10 | Pass (no evidence of causing delayed dermal contact | |
| sensitization) |
Table 5. Biocompatibility Testing of the Bose Hearing Aid
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All tests were passed and confirm that the Bose Hearing Aid met the requirement for biocompatibility.
REPROCESSING VALIDATION
The Bose Hearing Aid is provided non-sterile. The Earbud nozzles and Neckband may be wiped with a soft, dry cloth, and the StayHear+ tips may also be rinsed with warm water and thoroughly dried before attaching them to the earbuds. Liquid cleaners or solvents should not be used on any parts of the device because they may cause damage to the components.
SOFTWARE
The Bose Hearing Aid software consists of device firmware and mobile applications. The Bose Hearing Aid software is designed with ISO 13485 guidance, in compliance with the company's quality system requirements under risk management and software development and tested pursuant to IEC 62304:2006+A1:2015. Software documentation was submitted and reviewed using the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The Bose Hear mobile applications allow the parametric settings of the hearing aid to be adjusted. These settings are transmitted via Bluetooth to the Bose Hearing Aid into which the device firmware implements these desired changes.
The main elements of the software include:
- . Device Firmware
- Mobile applications for iOS and Android ●
Software Description
Bose Hearing Aid Mobile Application(s)
This mobile application is designed to function with a user's compatible personal smartphone or tablet device. It is available for download on iOS or Android based systems from the Apple Store and Google Play store respectively. The Bose Hear mobile application is used to set and control audiological gain parameters as well as device settings on the Bose Hearing Aid.
Device Software Hazard Analysis
The submitted Bose Hearing Aid Risk Management File identifies software (and hardware) hazards associated with the device. This file contains detail on the following:
- nature of the hazardous event
- severity of the hazard
- cause(s) of the hazard ●
- method of control (e.g., alarm, hardware design) .
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- corrective measures taken, including an explanation of the aspects of the . device
- design/requirements, that eliminate, reduce, or warn of a hazardous event; and ●
- verification that the method of control was implemented correctly. ●
Software Requirement Specification
A summary of software requirements related to the Bose Hearing Aid was submitted and found acceptable.
Traceability Analysis
A traceability matrix for the Bose Hearing Aid was provided in the submission that provides evidence of the safety-related requirements for the Bose Hearing Aid.
Verification and Validation
Key testing approaches, activities, testable configurations and verification responsibilities were conducted and documented. The software was verified using functional testing against requirements, unit tests and moreover, the clinical study validates that the selffitting method functions as designed. Testing found no major defects for safety related features of the device software and firmware. The software is version controlled and the revision history is maintained. The latest version is 1.3.0 for the DSP firmware; versions 1.01.00 and 1.1 for the Mobile Droid App and the Mobile iOS App, respectively.
SUMMARY OF CLINICAL INFORMATION
The following is a summary of two clinical studies and a human factors study performed by the sponsor to support a reasonable assurance of safety and effectiveness for the Bose Hearing Aid.
The Bose Hearing Aid allows users to control and customize signal processing parameters to their hearing needs via the Bose user interface, which consists of two Dimension-Reduced Controllers (DRCs) ("Loudness" and "Fine Tuning") implemented in an application running on a mobile device. Two clinical studies (Phase I and Phase II) and a human factors study were conducted to validate the self-fitting methodology for the Bose Hearing Aid.
Phase I Study: Laboratory Evaluation of Validity of Bose Self-Fitting Method
The Phase I study was a laboratory study with a simulated hearing aid on which the DRCs were implemented to determine the reliability and validity of the DRC method for user self-fitting of signal processing parameters. Fifty adult subjects (49 with mild to severe hearing loss, 1 with normal hearing) set the DRC under minimal supervision while listening to a variety of different recorded stimuli. The results demonstrated that 1) the Bose self-fitting method is reliable as the average test-retest error was 3.9 dB, which was within the 4 dB test-retest reliability of the probe microphone measurements used in real-ear verification of hearing aid fittings; 2) the Bose selffitting method is valid as the average deviation from NAL-NL2 prescribed gain for subjectselected gain was 5 dB, which was in line with published reports of preferred gain settings after
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post-fitting fine tuning; and 3) the sound quality provided by the Bose self-fitting method is sufficient as the prescribed parameters were not significantly more preferred than the subjectselected ones. Overall, the Phase I study provides evidence that the Bose Self-Fitting method results in outcomes not inferior to professional fitting for adults with mild to moderate hearing loss.
Phase II Study: Clinical Validation of Bose Self-Fitting Method
Overall study design
A prospective, two-arm, pre-market study was conducted among 75 adult subjects with mild to moderately severe hearing loss to validate the effectiveness of the Bose Self-Fitting Method by comparing outcomes with self-fitting using the Bose DRCs to those with professional fitting of the same hearing aids. All subjects participated in three clinic visits (1-First Fit, 2-Fine-Tuning, and 3-Assessment) as well as several weeks of Bose prototype hearing aid use in the field (Figure 4). During the first two sessions, all subjects were fit professionally with a prototype version of the Bose Hearing Aid by one of several participating licensed audiologists using a custom professional fitting application. Subjects were then assigned for a one-month field trial to either a "Pro-Fit" Group (audiologist fit only, with limited program and volume control via mobile device, as would be the case for a typical professionally-fit hearing aid) or a "Self-Fit" Group (no access to audiologist fit, self-fit via Bose Hear mobile app implementing DRCs). In Session 3, all subjects returned to complete a speech-in-noise test as well as a series of questionnaires assessing benefit associated with the hearing aid. We note that the primary goal of the clinical studies was to validate the self-fitting strategy (DRCs), and patient self-selection was not directly evaluated. Individuals with normal hearing and individuals with severe to profound hearing loss were excluded from the study. Furthermore, in order to compare user-derived gain settings to professionally-(audiologist) derived settings within subjects, all subjects were fitted initially with the Bose Hearing Aid by an audiologist, including selection of the eartips. Thus, selection of the eartips was evaluated in a separate human factors study. The between-group design also enabled comparison between audiologist-based (Pro-Fit Group) and participantbased (Self-Fit) hearing aid fitting on multiple outcome measures as described below.
Image /page/13/Figure/4 description: The image shows the title of a figure. The title is "Figure 4. Experiment Timeline". The title is written in a bold, sans-serif font. The title is centered on the image.
Image /page/13/Figure/5 description: The image shows a diagram of the PRO-FIT and SELF-FIT groups. Session 1 is labeled "FIRST FIT", Session 2 is labeled "FINE TUNING", and Session 3 is labeled "ASSESSMENT". The PRO-FIT group has a field use of 5.3 days between sessions 1 and 2, and 30.2 days between sessions 2 and 3.
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Demographics
The table below provides information on subject demographics by group and analysis for the Phase II study.
Table 6. Subject Demographics
| All subs | ||
|---|---|---|
| Pro-Fit | Self-Fit | |
| Sample Size | 37 | 38 |
| 4FA AC Threshold (dB HL; mean, s.d.) | 28.8 , 9.2 | 32.5 , 12.2 |
| Sensorineural* (# participants) | 30 | 34 |
| Conductive* (# participants) | 1 | 0 |
| Mixed* (# participants) | 1 | 1 |
| Asymmetric† (# participants) | 1 | 1 |
| New Hearing Aid Users‡(# participants) | 33 | 28 |
| Experienced Hearing Aid Users‡ (# participants) | 4 | 10 |
| Age (years) mean, s.d. | 62 , 13.4 | 66.1 , 12 |
| Female (# participants) | 19 | 20 |
*Conductive component if Air Bone Gap ≥ 15 dB at 500, 100, and 2000 Hz.
Study Results
Safety Results
The primary safety endpoint is evaluations of Adverse Events (AEs) and Serious Adverse Events (SAEs). There were no AEs or SAEs occurring for any subject over the course of the study.
Effectiveness Results
Primary Endpoint
The primary effectiveness endpoint was the comparison of prescribed hearing aid settings versus DRC user-selected settings with respect to sound quality. The sound quality would be considered to be sufficient if the prescribed parameters were not significantly more preferred than the DRCselected ones.
Subjects in the Self-Fit Group were satisfied with/preferred their own settings to the professionally-selected settings more than were/did subjects in the Pro-Fit Group. Subjects in the Self-Fit group preferred the set of signal processing parameters that they selected with the DRC's significantly (p