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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

Study Details

1. A table of acceptance criteria and the reported device performance: See table above.

2. Sample size used for the test set and the data provenance:

   • Clinical Performance Study: 93 adults were initially enrolled, with 92 participants providing data for analysis (45 Self-Fit, 47 Pro-Fit).
     • Provenance: Prospective, multicenter, randomized, single-blind, parallel-arm study. The study was conducted adhere to COVID-19 social distancing needs. The text does not explicitly state the country of origin, but the submission is to the U.S. FDA suggesting a U.S. based or internationally recognized standard study.
   • Usability Testing (Human Factors Study): 15 adults (18 years and older) with perceived mild to moderate hearing loss.
     • Provenance: Formative and Summative Evaluations conducted in a one-on-one quiet, comfortable room. No country of origin specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Clinical Performance Study: The "Pro-fit" arm served as a comparative ground truth, where licensed professionals (audiologists, as implied by the context of "licensed professional-fit" using "commercially available fitting software") fitted the hearing aids. The text doesn't specify the number of individual audiologists or their years of experience but indicates they used "best practice fitting algorithms" and were "licensed."
   • Usability Testing: An "independent, trained moderator" conducted each session. A "cross-functional team" reviewed outcomes, but their direct role in establishing "ground truth" (beyond analyzing usability findings) is not clarified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Clinical Performance Study: The study design was a "multicenter, prospective, randomized, single-blind, parallel-arm study comparing outcomes of two fitting approaches: self-fitting... or licensed professional fitting." This implies a direct comparison of two defined groups rather than an adjudication process between multiple expert interpretations of a single case. There is no mention of an adjudication method in the traditional sense of resolving discrepancies in expert opinions.
   • Usability Testing: A "cross-functional team reviewed outcomes at frequent intervals and addressed changes to be considered to labeling, product packaging, and iterative minor design changes to the user interface." This suggests a collaborative review process rather than a formal adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • A traditional MRMC study, as typically applied to image-based diagnostic AI where human readers interpret cases with and without AI assistance, was not explicitly described.
   • However, the clinical performance study does compare "Self-fit" (which uses the Sentibo mobile app for self-fitting) to "Pro-fit" (licensed professional fitting). This is a comparative effectiveness study, but it's not in the context of an "AI assistance" model for human readers. It's comparing two different fitting methodologies for a hearing aid device.
   • Effect Size: The study demonstrated non-inferiority of the self-fit approach to professional fitting.
     • Satisfaction with Sound Quality: Self-fit mean = 2.84 (SD=0.93), Pro-fit mean = 2.72 (SD=1.14) (on a 5-point scale, where higher is better).
     • Satisfaction with Fitting Process: Self-fit mean = 3.22 (SD=0.95), Pro-fit mean = 3.11 (SD=1.07) (on a 5-point scale, where higher is better).
     • SSQ-12 Benefit Score: Self-fit mean = 6.8 (SD=1.7), Pro-fit mean = 6.5 (SD=1.5) (on a 0-10 scale).
     • APHAB Global Score: Self-fit mean = 10.0 (SD=17.3), Pro-fit mean = 12.8 (SD=19.7).
     • The phrasing "similar levels of satisfaction" and "similar levels of perceived benefit" indicates that the self-fit (AI/app-driven) method performed comparably to professional fitting, demonstrating non-inferiority rather than an "improvement with AI assistance" over a human baseline.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The "Self-fit" arm of the clinical study, which utilized the "Sentibo OTC mobile app" for fitting, represents a standalone algorithm managing the fitting process, with the user's input as part of the algorithm's execution, rather than an audiologist's direct intervention. The user makes selections based on listening to digitized speech through Apple EarPods. Therefore, the "Self-fit" group in the clinical performance study effectively assessed the standalone performance of the algorithm in guiding the user to fit the device without professional assistance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Clinical Performance Study: The ground truth for comparative effectiveness was established by the outcomes of licensed professional fitting (Pro-fit group) using "best practice fitting algorithms" and NAL-NL2 targets, against which the self-fit outcomes were compared for non-inferiority. Subjective outcomes (satisfaction, APHAB, SSQ-12) and objective simulated real-ear measures (matching NAL-NL2 targets) were used.
   • Usability Testing: The ground truth was based on the successful completion of tasks by participants and the identification of "critical/essential tasks," reviewed by a cross-functional team.

8. The sample size for the training set:

   • The document does not explicitly state a sample size for a training set for the Sentibo self-fitting algorithm. This type of information (how the algorithm itself was developed or trained on data) is typically for the development stage and not always detailed in an FDA 510(k) summary focused on validation. The Sentibo app offers "24 predefined options" that the user selects from, suggesting a pre-programmed or pre-trained model rather than a user-adaptive learning system that "trains" on user data during the fitting process.

9. How the ground truth for the training set was established:

   • As the training set size is not provided, the method for establishing its ground truth is also not detailed. However, the description of the self-fitting method for the Lumen 155-SF states it "uses digitized human voice" for selection, and that its fitting method is "adequate for fitting mild to moderate hearing loss, the same as prescribed by NAL-NL2." This suggests that the underlying principles and "ground truth" for the algorithm's output (i.e., the 24 predefined options) are based on established audiological standards like NAL-NL2 or similar validated fitting algorithms for different hearing loss profiles. The predicate device uses a validated NAL-NL2 fitting algorithm, and the subject device's method is compared to this standard.

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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

Study Details

The document largely relies on the clinical data from the predicate device (DEN180026) for the "clinical performance" aspect, and describes a human factors validation study for the new device.

1. Sample size used for the test set and the data provenance:

   • Clinical Data (from predicate DEN180026, applied to K211008):
     • "demonstrated that Bose SoundControl Hearing Aids deliver adequate amplification to compensate for mild to moderate hearing loss (Figure 1)." This figure states "REAR was obtained in 34 ears".
     • The original predicate study's sample size is not explicitly stated in this document, but implied by the "not in any way inferior to professional fitting" and "patient satisfaction and preference reports" from the self-fit group.
     • Data Provenance: Not specified, but likely prospective clinical study given the nature of the "not inferior" claim and "patient satisfaction" reports. Country of origin not stated.
   • Human Factors Validation Test (for Bose SoundControl Hearing Aids K211008):
     • 20 untrained participants representing the intended user population (individuals 18 years of age or older with perceived mild to moderate hearing impairment).
     • Data Provenance: This would be a prospective study specifically for the K211008 device. Country of origin not stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Clinical Data (predicate study): Not explicitly stated how many experts or their qualifications were involved in establishing "professional fitting" as ground truth or assessing outcomes like patient satisfaction. The NAL-NL2 amplification targets are a standardized method, not requiring expert consensus for setting targets, but their application and assessment would involve audiologists.
   • Human Factors Validation Test: The concept of "ground truth" doesn't directly apply here in the same medical sense. The study aimed to assess safe and effective use by the intended user (untrained participants) interacting with the device and documentation. The "truth" is whether they could complete tasks safely and effectively.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified for any of the studies mentioned.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was not done. This type of study (MRMC for AI assistance) is not relevant for a self-fitting hearing aid where the "AI" (self-fitting algorithm) works directly with the user, rather than assisting a human reader in interpreting medical images/data. The focus is on the device's direct performance and user interaction.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The "standalone" performance here would be the electroacoustic measurements (OSPL90, FOG, RTG, etc.) as measured in a 2cc coupler, which are standard hearing aid performance metrics. These were compared for the Bose SoundControl Hearing Aids to the predicate device.
   • The "clinical validation study" demonstrating "adequate amplification" (Figure 1) is also a form of objective performance measurement in ears, but it still relates to the output of the device after self-fitting, rather than a completely isolated algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Clinical Data (Predicate):
     • The ground truth for comparison appears to be "professional fitting" of hearing aids by a hearing care professional. User satisfaction and preference are also forms of outcome data collected.
     • For the "adequate amplification" claim, the NAL-NL2 amplification targets are a well-established, evidence-based prescriptive method in audiology, serving as a "ground truth" for appropriate gain delivery.
   • Human Factors Study: The "ground truth" is the safety and effectiveness of user interaction with the device, which is assessed through participants' ability to complete tasks and subjective feedback.

7. The sample size for the training set:

   • Not specified. The document focuses on the validation and testing sets. Details of the training data (if any for the self-fitting algorithm's development) are not provided in this 510(k) summary. The summary states: "Device firmware is derived from the DEN180026 device with minor modifications... Software is derived from the DEN180026 with minor modifications... There has been no change from the Self-Fit technology demonstrated in the predicate device submission." This suggests the core self-fitting technology was established and 'trained' (or developed) as part of the predicate, and not fundamentally changed or re-trained for this new device.

8. How the ground truth for the training set was established:

   • Not specified as the training set and its ground truth establishment are not discussed in this 510(k) summary, likely because the core self-fitting algorithm was inherited from the predicate device.

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