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510(k) Data Aggregation
(292 days)
QDD
The Lumen® 155-SF self-fitting, wireless air conduction hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. The device is intended for over-the-counter sales without the assistance of a hearing health care professional.
Per 21 CFR 874.3325 a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are class II medical devices.
The Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (Lumen 155-SF) | Predicate/Reference Performance | Discussion of Differences & Meeting Criteria |
|---|---|---|---|---|
| Intended Use | Amplifies sound for adults 18+ with perceived mild to moderate hearing impairment; user-adjusted; OTC sales without hearing health professional assistance. | Meets this exact indication. | Predicate (Nuheara IQbuds 2 PRO) and Reference (Bose SoundControl) have similar intended uses. | Lumen 155-SF's intended use is substantially equivalent to the predicate and reference devices. Minor wording changes in the intended use statement are considered redundant in context of a self-fitting hearing aid. |
| Electro-Acoustic Characteristics (ANSI/ASA S3.22 & ANSI/CTA 2051) | Latency ≤ 15 ms | 5.8 ms | Predicate: 5 ms; Reference: 5.5 ms | Meets criteria of being ≤ 15 ms. Within measurement uncertainty tolerance of predicate/reference. |
| Frequency Response |
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(182 days)
QDD
The Vibe SF seff-fitting 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's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
The EasyFit self-fitting web application is intended to support self-fitting and fine-tuning of the Vibe SF hearing aid.
The Vibe SF Self-Fitting Hearing Aid ("Vibe SF") is a self-fitting air conduction hearing aid 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.
The Vibe SF hearing aid is based on WSAUD's wireless hearing aid series Signia Silk 1X (regulated under 21 C.F.R. § 874.3305). However, unlike standard wireless air-conduction hearing aids, the Vibe SF is intended to be sold directly to the end-user without involvement of a hearing care professional. Briefly, the self-fitting hearing aid system consists of two components:
- a) A wireless hearing aid with a self-fitting feature (Vibe SF); and
- b) A mobile web application (EasyFit) to support the self-fitting and fine-tuning of the hearing aid.
The Vibe SF wireless hearing aid hardware includes: Ear pieces (click sleeves), housing, circuit board, battery, chip, and electroacoustic components. The subject device is fitted for bilateral use with a left and right device. Left and right hearing aids are able to communicate with each other over a magnetic inductive wireless link. The instant fit in-the-ear (ITE) style of the Vibe SF hearing aid uses Click Sleeves in 4 different sizes to couple with the ear canal. The hearing aids are marked with 'R' for right and 'L' for left, and are powered by standard (non-rechargeable) Zinc-Air batteries (size 10A). The Vibe SF hearing aid includes software that communicates with the EasyFit app to provide self-fitting functionality.
The Vibe SF is fitted by the user through the EasyFit self-fitting web application, which is run on an Internet browser on the user's mobile device (smartphone or tablet with iOS or Android operating system). The EasyFit self-fitting web application guides the user through the selffitting procedure and also allows the user to set audiological gain parameters and preferred settings on the Vibe SF Hearing Aid. In addition, a software application (app for iOS and Android) called Vibe app is available as remote control for adjusting volume during daily use.
Here's a breakdown of the acceptance criteria and study details for the Vibe SF Self-Fitting Hearing Aid, based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary objective of the clinical study was to demonstrate non-inferiority of the Vibe SF self-fitting strategy compared to an audiologist-fit (HCP fit) strategy regarding perceived hearing aid benefit. This was measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) subscales for ease of communication (EC), background noise (BN), and reverberant room (RV).
The acceptance criterion for effectiveness was simultaneous non-inferiority on all three APHAB subscales.
| Acceptance Criterion (Effectiveness) | Reported Device Performance |
|---|---|
| Non-inferiority of Vibe SF self-fitting strategy compared to HCP-fit strategy on all three subscales of APHAB (EC, BN, RV). | Achieved. The Vibe SF strategy was non-inferior to the HCP fit strategy in each of the 3 benefit scores for each subscale in the APHAB (**p |
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(183 days)
QDD
The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are 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.
The MDHearing Smart Hearing Aid is a self-fitting wireless air conduction hearing aid system consisting of the Intricon Lumen 200B hardware and the MDHearing mobile application, which is an "app" compatible only with MDHearing devices of a Smart Hearing Aid product line, designed to interface with a user's compatible smartphone or tablet to personalize and manipulate the device and its settings. The wireless hearing aid incorporates microphones and a receiver encased in the behind-the-ear (BTE) hearing aid body, delivering amplified sound to the ear via standard thin tubing coupled to an earpiece for audio input into the ear. The hearing aid can be controlled wirelessly via Bluetooth Low Energy® using the MDHearing app or manually with on-device push buttons for changing volume and programs. The controls accessible through the MDHearing app and on the hearing aids are used to configure parameters, settings, and listening modes of the devices. The MDHearing Smart Hearing Aid is powered by a standard disposable size 312 zinc-air hearing aid battery.
The provided text describes the MDHearing Smart Hearing Aid and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose® Hearing Aid). The primary focus of the clinical performance testing was to show that self-fitting the device produced outcomes non-inferior to a professional fitting.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The clinical performance validation aimed to demonstrate non-inferiority of the self-fit MDHearing Smart Hearing Aid compared to the same device professionally fit. The primary test metrics were user-reported (subjective) aided benefit using two standard questionnaires: the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the 12-item short form of the Speech, Spatial and Qualities of Hearing scale (SSQ12). A secondary metric was speech-in-noise recognition using the QuickSIN test.
The text states: "The study results demonstrated that the MDHearing Smart Hearing Aid was non-inferior to fitting by a hearing care professional for both subjective and objective measures of hearing aid benefit."
The specific acceptance criteria (e.g., non-inferiority margins) are not explicitly stated as numerical thresholds in this document, but the graphical representations (Figure 2b and Figure 3b) show confidence intervals relative to a non-inferiority margin (-δ). The conclusion is that these intervals did not extend beyond the non-inferiority boundary.
Table of Acceptance Criteria and Reported Device Performance (Summary based on text):
| Acceptance Criteria (Implicit from study design for Non-Inferiority) | Reported Device Performance |
|---|---|
| Primary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (APHAB Global Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2a and 2b) |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (SSQ12 Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2c and 2d) |
| Secondary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Speech-In-Noise Recognition (QuickSIN) | No difference in speech-in-noise intelligibility benefit between self-fit and professional-fit groups, with subjectively comparable score distributions. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 3a and 3b) |
| Reliability of self-fitting method (Probe-Microphone Real Ear Measures - REAG) | Mean absolute difference (MAD) in real-ear measures of average gain significantly less than 2 dB (p |
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(90 days)
QDD
The Jabra Enhance Plus self-fitting 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.
The Jabra Enhance Plus is a wireless, self-fitting air-conduction hearing aid system. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth Low Energy using the mobile app, the Jabra Enhance, installed on a compatible iPhone, iOS 14 or later. Further control of the earbuds is possible via an on-device user control button on both the Left and Right earbud. In addition to hearing aid functionality for environmental listening, the Jabra Enhance Plus earbuds can be used for placing and receiving telephone calls and for streaming audio from a compatible, Bluetooth compliant mobile device that has been paired with the earbuds. The controls accessible through the Jabra Enhance mobile app and on the earbuds are used to configure parameters, settings, and listening modes of the earbuds. The earbuds integrate a rechargeable 3.7V/15mAh li-ion battery coin cell inside each earbud, and they are recharged by the on-the-go charging case that also serves as a carrying case. The mobile app is connected to the Internet Services that enable remote upgrades to the earbud firmware in support of continued enhancements.
The provided document is a 510(k) Summary for the Jabra Enhance Plus self-fitting air-conduction hearing aid. It outlines the device's characteristics, comparison to a predicate device (Bose Hearing Aid), and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state acceptance criteria in numerical targets for all aspects, but rather compares the Jabra Enhance Plus (Subject Device) to a predicate device (Bose Hearing Aid) and relevant standards. The "Discussion" column often acts as a statement of meeting implied criteria (e.g., "Same as predicate," "Comparable to predicate and suitable for the intended user"). Performance is reported against technical standards and clinical equivalence.
| Evaluation Criterion / Characteristic | Acceptance Criteria (Implied/Standard) | Reported Device Performance (Jabra Enhance Plus) | Discussion (Meeting Acceptance) |
|---|---|---|---|
| Indications for Use | Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment, self-adjusted, no pre-programming/hearing test, direct-to-consumer, no professional assistance) | Same as predicate | Met: "The Indications for Use are the same." |
| Intended Use | Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment) | Same as predicate | Met: "The intended uses are the same." |
| Technological Characteristics | |||
| Housing | Biocompatibility and safety characteristics comparable to predicate. | In-ear earbuds (different from predicate's neckband) | Met: "difference in housing does not raise different questions of safety or effectiveness. Biological safety characteristics same as predicate device. Nonclinical data from biological safety testing and data from a clinical validation study support substantial equivalence." |
| Wireless communication | Wireless communication with handheld device via Bluetooth | Wireless communication with handheld device via Bluetooth | Met: "Same as predicate" |
| Wireless coexistence | Complies with AAMI TIR 69 (temporary loss of Bluetooth communication a negligible risk) | Uses 2.4GHz Classic Bluetooth and BLE; risk assessment determined temporary loss of Bluetooth communication from interfering RF signals is negligible. | Met: "Same as predicate" |
| Wireless user control functions via mobile app | Functionally similar to predicate. Fine-tuning options typical for mild-moderate hearing loss. | Volume Control (-12dB to +6dB), Listen Mode (Surround, adaptive, focus), Preferred filter (full, normal, clear) | Met: "Bose Hearing Aid allows for Left/Right balance control, however Left/Right balance is achieved through the self-fitting process in the subject device and as such, is inherent in the self-fitted device. The additional Bose Left/Right balance does not raise different questions of safety or effectiveness. Nonclinical data from a formative usability study and data a clinical validation study support substantial equivalence." |
| Bluetooth pairing, control, streaming | Verification with paired mobile device | Pairing, control, streaming verification with the paired mobile device. | Met: "Same as predicate" |
| Battery life | Rechargeable, providing ~10 hours of battery life | Rechargeable 3.7V/15mAh li-ion battery coin cells, 10 hours battery life (implied from discussion) | Met: "While battery capacity is different, both devices are rechargeable and allow for 10 hours of battery life on a full charge, and as such the difference in battery capacity does not raise different questions of safety or effectiveness." |
| Charging | Safe charging method not raising new questions of safety/effectiveness | Proprietary On-The-Go charging case via physical connection (Pogo pins), with internal 3.7V/129mAh li-ion battery for on-the-go charging, supports USB power. | Met: "Charging the subject device hearing aids in a portable charging case with or without connecting the charging case to a power supply via a USB cable does not raise different questions of safety or effectiveness. Non-clinical data from a formative usability study support substantial equivalence." |
| Microphones | Omnidirectional and directional modes, suitable for intended use. | Omnidirectional or directional modes (Surround, adaptive, focus). Supports adaptive directional mode. | Met: "The added automatic selection of directionality does not raise different questions of safety or effectiveness... Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence." |
| Device control | Comparable to predicate, not raising new safety/effectiveness questions. | On-Device user controls for volume, mute, mobile calls. Bluetooth pairing via removal from charging case. | Met: "The added call controls and different means of engaging BlueTooth pairing do not raise new questions for safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence." |
| Compression | Channels allowing for similar spectral tilt as predicate. | 17 channel wide band dynamic range compression | Met: "The 5 additional channels... offer similar spectral tilt as predicate device. The 5 additional channels do not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence." |
| Noise reduction | Proven effective, not raising new safety/effectiveness questions. | Steady-state noise reduction, impact noise control. No active noise reduction. (Different from predicate). | Met: "While differences in the implementation of noise cancellation exist, the methods developed by GN Hearing have proven effective in products already on the market, and therefore do not raise different questions of safety or effectiveness. Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence." |
| Feedback cancellation | Feedback canceller present | Feedback canceller | Met: "Same as Predicate" |
| Telephone calls | Placing and receiving telephone calls capability | Placing and receiving telephone calls | Met: "Same as Predicate" |
| Mobile App compatibility | Not raising different safety/effectiveness questions even with reduced compatibility. | iOS only (Predicate compatible with iOS & Android). | Met: "The lack of compatibility with handheld Android devices does not raise different questions of safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence." |
| Self-fitting method | Validated algorithm, not raising different safety/effectiveness questions. | NAL-NL2 fitting algorithm | Met: "NAL-NL2 is widely used by hearing care professionals... As such the difference in fitting does not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence." |
| Remote Firmware update | Cybersecurity risks assessed and mitigated, not raising different safety/effectiveness questions. | Allows remote firmware update via app/cloud. | Met: "This feature does not raise different questions of safety or effectiveness. Nonclinical data documented in the cyber risk register support substantial equivalence." |
| Exposure to nonionizing radiation (IEC 62479:2010) | Sufficiently safe in terms of human exposure to nonionizing radiation. | Passes according to IEC 62479:2010. | Met: "Comparable to predicate. Uses same Bluetooth technology. Nonclinical data from verification testing in accordance with IEC 62478:2010 (human exposure to electromagnetic fields) support substantial equivalence." |
| Electroacoustic characteristics (ANSI/ASA S3.22-2014 & ANSI/CTA 2051:2017) | Comparable to predicate and suitable for intended user. Latency |
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(141 days)
QDD
The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid, 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. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.
The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid. It features digital signal processing (16 channel-wide dynamic input compression, 3 channel fast-acting output compression, 16 channel noise reduction, feedback cancellation,) bi-directional microphone with windscreen, volume and program control (environment selection - Quiet, Noisy, Concert, TV), 3 channel equalizer, self-adjustable wire and ear tips, and customization through the Braun® Clear™ Mobile Application. The Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Braun® Clear™ Hearing Aid. These thresholds are used to program the device using a proprietary fitting algorithm.
This document describes a medical device, the BHA100 Series Braun® Clear™ Hearing Aid, and its supporting clinical study. The device is a self-fitting, air conduction hearing aid intended for individuals 18 years or older with perceived mild to moderate hearing impairment, for direct-to-consumer use without professional assistance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a single table labeled "acceptance criteria" with a clear pass/fail status for each, but the study results are presented against implicit or stated criteria. I've synthesized these from the descriptions of the primary and secondary endpoints.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance and Confidence Interval (95% CI) | Pass/Fail (Interpreted) |
|---|---|---|
| Phase 1 Primary Endpoint: Mean Absolute Difference (MAD) between self-fitting and audiologist-executed Pure Tone Average (PTA) thresholds (dB) |
- Within the 10 dB margin of the acceptance criteria. | MAD: 2.8 dB
- 95% CI: 2.4 dB to 3.2 dB
- p
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(30 days)
QDD
The Bose SoundControl™ Hearing Aids 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's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).
Per 21 CFR 874.3325 a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are class II medical devices.
The Bose SoundControl Hearing Aids (Model BMD0012) are self-fitting wireless air conduction hearing aids consisting of the Novidan Inc. hardware, Bose software, the Bose Hear app, and accessories supplied in the carton.
Each hearing aid in the pair functions and interacts with the Bose Hear app independently and as a system. The hearing aids are powered by a disposable size 312 zinc-air battery. The hearing aids incorporate microphones for audio input and sound is delivered to the ear via a receiver that can be coupled with open or closed domes. The hearing aids are controlled via on-board button controls and wirelessly via the Bose Hear app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.
The provided text is a 510(k) Summary for the Bose SoundControl Hearing Aids (K211008). It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose Hearing Aid, DEN180026).
However, the document does not provide specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format of a clinical trial report with defined endpoints and statistical analysis. Instead, it argues for substantial equivalence primarily through comparison to a well-established predicate device and various non-clinical and human factors testing.
It states: "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." but does not enumerate these criteria beyond the test names.
Let's break down what information is available and what is missing based on your request.
Acceptance Criteria and Device Performance
The document doesn't explicitly state quantitative acceptance criteria for clinical performance of the Bose SoundControl Hearing Aids, but rather bases its claims on "substantial equivalence" to a predicate device and adequacy for fitting mild to moderate hearing loss. The "results" section primarily refers to "Pass" for various engineering and safety tests.
It also highlights the outcomes of a clinical study for the predicate device, stating it resulted in "outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss" and that "subjects in the Self-Fit Group were satisfied with and preferred their own self-adjusted settings to the professionally-selected settings." This is then extrapolated to the new device because the self-fitting method is the same.
A table summarizing the comparison to the predicate device's ANSI S3.22 data is provided, which serves as a form of acceptance criteria (i.e., being "Same" or "Adequate").
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Bose SoundControl Hearing Aids) | Discussion/Predicate Performance |
|---|---|---|---|
| Electrical Safety | Pass (per IEC 60601-1, IEC 60601-2-66, IEC 60601-1-11) | Pass | Satisfied requirements |
| Electromagnetic Compatibility (EMC) | Pass (per IEC 60601-1-2) | Pass | Satisfied requirements |
| Electroacoustic Performance | Pass (per ANSI/ASA S3.22 2014) | Pass | Satisfied requirements |
| Usability Engineering | Pass (per Bose-specified procedure, IEC 60601-1-6) | Pass | Safe and effective for intended users, uses, and environments |
| Biocompatibility | Pass (per ISO 10993-1, ISO 10993-5, ISO 10993-10) | Pass | Satisfied requirements |
| Software | Pass (per IEC 62304) | Pass | Satisfied requirements |
| Max OSPL90 | Equivalent to predicate (115 dBSPL), or adequate for fitting moderate hearing loss. | 113 dBSPL | "Same" as predicate (115 dBSPL) |
| HFA OSPL90 | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 106 dBSPL | Predicate: 112 dBSPL. Considered "Adequate" |
| HFA FOG | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 30 dB | Predicate: 43 dB. Considered "Adequate" |
| RTG | Adequate for fitting moderate hearing loss (55 dBHL) as prescribed by NAL-NL2. | 29 dB | Predicate: 36 dB. Considered "Adequate" |
| Frequency Response | Equivalent to predicate's range. | 8000 Hz) | |
| Harmonic Distortion | Equivalent to predicate's levels. |
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(147 days)
QDD
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the Bose Hearing Aid meets them, based on the provided text.
Acceptance Criteria and Device Performance
The Bose Hearing Aid underwent various tests to demonstrate its safety and effectiveness. These tests included electrical and battery safety, electromagnetic compatibility, mechanical performance, electroacoustic performance, usability engineering, and biocompatibility.
Here's a table summarizing the acceptance criteria and the reported device performance for several key areas:
| Test Category | Acceptance Criteria | Reported Device Performance | Study Proving Acceptance |
|---|---|---|---|
| Electrical & Wireless | Overvoltage Protection: |
- Draws 127 mA ± 20 mA (proper charging) within permissible operating voltage
- Continues charging down to 4.4V
- Continues charging up to at least 6.8V and no higher than 8.45V
- Draws no more than 2.5 mA beyond upper limit (protection circuitry function)
Wireless Technology: - Pairing, control, streaming verification with paired mobile device. | Overvoltage Protection: Pass
Wireless Technology: Pass | Non-clinical/Bench Studies - Electrical Testing (Table 2) |
| Mechanical | Neckband Fit: - Meet neckband opening and cord length design to accommodate the 5th to 95th percentile range of user anatomy (per 1988 Anthropometric Survey). | All requirements and expected measurements were within specified range. Accepted/Passed. | Non-clinical/Bench Studies - Mechanical Testing (Table 3) |
| Electroacoustic | Frequency Response Bandwidth: At least 250 Hz – 5 kHz
Maximum Acoustic Output: Less than or equal to 120 dB SPL
Output Distortion: Less than or equal to 5%
Input Distortion: Less than or equal to 5% (at 500 Hz, 100 dB SPL input, 80 dB SPL output)
EIN (Equivalent Input Noise): Less than or equal to 32 dB SPL
Latency: Less than or equal to 15 ms
Directionality: Room sound audible in both ears, scratching sound in left/right ear, silence in one ear with room sound in other, room sound only in one ear with no scratching. | All Pass | Non-clinical/Bench Studies - Electroacoustic Performance (Table 4) and Monaural/Binaural Directionality Verification (page 10). |
| Biocompatibility | Cytotoxicity (ISO 10993-5): No evidence of causing cell lysis or toxicity
Irritation (ISO 10993-10): Pass
Skin Sensitization (ISO 10993-10): No evidence of causing delayed dermal contact sensitization | Cytotoxicity: Pass (Grade 0)
Irritation: Pass (test score 0.0 and 0.1)
Skin Sensitization: Pass | Non-clinical/Bench Studies - Biocompatibility (Table 5) |
| Usability | Risks resulting from normal use and use errors are assessed and mitigated. Users can correctly use the device as intended under anticipated conditions of use. | Usability of the Bose hearing aid was analyzed, verified, and validated for its intended use, and implemented mitigations for user training and device labeling are adequate. User instructions and training materials were successful in allowing users to complete appropriate tasks. | Human Factors Study (described on page 18-19) |
| Effectiveness (Self-Fitting) | Primary Endpoint (Sound Quality): Prescribed parameters not significantly more preferred than DRC-selected ones.
Secondary Endpoints: - Speech-in-noise recognition performance (QuickSIN) of Self-Fit group significantly non-inferior to Pro-Fit group.
- Patient-reported outcomes (APHAB & SSQ-12) of Self-Fit group significantly non-inferior to Pro-Fit group.
- User-selected gain correlated with professionally-selected gain and comparable. | Primary Endpoint: Subjects in Self-Fit Group preferred their own settings more than professionally-selected settings (p
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