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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 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.

1. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study/Test Set): 28 subjects.
• Data Provenance: Single study site in the United States. The study design was a single-arm randomized crossover study, where subjects served as their own control, comparing the self-fitted Vibe SF (investigational device) to the Silk 1X HCP fit (comparator device) in real-life conditions. This indicates a prospective study.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth for the "HCP fit" arm was established by a hearing care professional (HCP). The document doesn't specify the exact number of HCPs involved in fitting the devices for the comparison, nor their specific qualifications (e.g., years of experience). However, it implies that the HCP fit leveraged "recognized prescriptive targets from the NAL-NL2" (National Acoustic Laboratories' Nonlinear Version 2).

3. Adjudication Method for the Test Set

• The study was designed as a single-arm randomized crossover study with patients serving as their own control. This means each participant experienced both the self-fit and HCP-fit conditions. Therefore, no external adjudication of results was explicitly described in the context of expert review of the APHAB scores; the "ground truth" for the HCP arm was the HCP's fitting based on NAL-NL2.

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 comparative effectiveness study was not done in the traditional sense of evaluating human reader performance with and without AI assistance for interpretation. This study focused on comparing two different fitting strategies (self-fit vs. HCP-fit) for a self-fitting hearing aid, not on improving human clinician interpretation of diagnostic images or data with AI. The device itself (Vibe SF) is the "AI" component, providing the self-fitting algorithm.

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

• The study design inherently includes the user as part of the "self-fitting" algorithm's performance, as the user adjusts the device based on the software tools. While the self-fitting algorithm provided by the EasyFit web application is a core component, its performance is measured through the user's interaction and the resulting perceived benefit. Therefore, a pure "algorithm only" standalone performance without any user interaction/input was not explicitly described beyond the fundamental function of the self-fitting software guiding the user. The "Vibe SF strategy" itself is the "algorithm only" aspect, as it is the automated fitting process, but its effectiveness is measured via user outcomes.

6. The Type of Ground Truth Used

• The primary ground truth for the effectiveness endpoint was patient-reported benefit as measured by the APHAB questionnaire.
• For the comparative arm, the "truth" was the fitting performed by a hearing care professional (HCP) adhering to established prescriptive targets (NAL-NL2). This is a form of expert consensus/best practice.
• Secondary endpoints like QuickSIN scores and Real Ear Measurements provided objective measures to support the patient-reported outcomes, comparing the actual performance of the hearing aid with an objective standard (NAL-NL2 targets) for gain.

7. The Sample Size for the Training Set

• The document does not explicitly state the sample size of the training set for the Vibe SF's self-fitting algorithm. The provided information focuses on the clinical validation study (test set) for the device. The proprietary nature of the fitting algorithm suggests that the "training" would have occurred during its development, potentially using a different dataset or real-world data, which is not detailed here.

8. How the Ground Truth for the Training Set Was Established

• Similar to the training set size, the document does not detail how the ground truth for the training set was established for the self-fitting algorithm. It only mentions that the self-fitting strategy uses a "proprietary fitting algorithm" that integrates user input with a self-fitting strategy. This implies that the algorithm's development (and thus its "training") would have involved a methodology to define optimal hearing aid settings, likely based on audiological science, hearing models, and potentially existing patient data, but these specifics are not provided.

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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):

Study Details:

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

   • Clinical Performance Study (RCT):
     • Total participants: 64 adults (18 years or older with sensorineural hearing loss from mild to moderate degree).
     • Randomized 1:1 into two groups: 32 in "Professional-Fit" group and 32 in "Self-Fit" group.
     • Data provenance: Single-site clinical validation study. The country is not explicitly stated, but it's an FDA submission, implying a US study. The study was prospective ("randomized clinical validation study").
   • Reliability and Validity of Self-Fitting (in-lab):
     • 44 subjects (N = 88 ears) for the reliability measures (MAD in gain).
     • 58 ears (subset of professional-fit group) for comparison of user-preferred vs. clinician fine-tuned gain.
     • N=56 ears (28 participants) for REAR matching to NAL-NL2 targets.
   • Human Factors Study:
     • 20 untrained participants representing the intended user population.
   • Electroacoustic Performance (Non-Clinical):
     • Testing performed on the device itself, not on human subjects.

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

   • For the "Professional-Fit" arm of the clinical study, a clinician (presumably an audiologist or hearing care professional) programmed and fine-tuned the hearing aids "according to audiologic standards of care." The exact number and specific qualifications (e.g., years of experience) of these clinicians are not provided, only that they were "hearing care professionals" and "clinicians." Given it's a "single site" study, it likely involved a limited number of professionals.
   • For the self-fit group, the "ground truth" for comparison was the professional-fit group's performance. The subjective and objective outcome measures themselves served as a form of "ground truth" to compare the two fitting methods.

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

   • Not applicable in the context of this hearing aid study. This type of adjudication is typically used for image-based diagnostic studies where human readers evaluate image findings and reach a consensus. Here, the outcome measures are quantitative (questionnaire scores, QuickSIN, real-ear measures) or direct observation of user interaction (human factors). The "professional-fit" outcome served as a benchmark, not an adjudicated ground truth in the sense of expert consensus on an interpretation.

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:

   • An MRMC study was not conducted. This was a randomized controlled trial comparing two fitting methods (self-fit vs. professional-fit) for a hearing aid, not an AI-assisted diagnostic task involving human readers. The "AI" component is the self-fitting algorithm within the device and app. The language used (effect size of human readers improving with AI) is typically for AI in diagnostic imaging.

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

   • The "self-fitting" mechanism itself is the core of the algorithm's standalone performance in providing an initial fit and allowing user adjustments. The clinical study implicitly evaluates this by comparing outcomes of the "self-fit" group (who primarily relied on the algorithm and their own adjustments) to the "professional-fit" group.
   • The "Reliability and Validity of the MDHearing Self-Fitting Method" section described in-lab testing where probe-microphone measures were taken after user adjustments, evaluating the consistency and approximation of the self-selected gain to professionally selected targets (NAL-NL2), this could be considered a form of evaluating the algorithm's output through user interaction.

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

   • The primary ground truth for the clinical comparison was the outcomes data from the "professional-fit" group, which served as the benchmark for demonstrating non-inferiority.
     • Subjective Outcomes: Patient-reported measures (APHAB, SSQ12).
     • Objective Outcomes: Speech-in-noise recognition (QuickSIN) and Real Ear Measures (REMs) against prescribed NAL-NL2 targets (an audiologic standard).
   • For the human factors study, the ground truth was the observed ability of participants to safely and correctly operate the device and app, guided by pre-defined task completion criteria.

7. The sample size for the training set:

   • The document does not explicitly state a separate training set size for the self-fitting algorithm. The NAL-NL2 fitting formula, which the device utilizes, is a well-established, validated prescriptive algorithm for hearing aid fitting, developed based on extensive audiological research and data. It's not a machine learning model that's "trained" in the typical sense on a specific dataset for this device. The app personalizes settings based on user input, which then applies this pre-established NAL-NL2 formula for the initial fit.

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

   • As noted above, the device uses the NAL-NL2 fitting formula, which is a widely accepted audiological standard, not a data-trained algorithm in the modern AI sense. Therefore, there wasn't a "training set" for this specific device's algorithm that required establishing ground truth by human experts. The "ground truth" for NAL-NL2 itself comes from decades of audiological research and clinical consensus on optimal gain targets for speech intelligibility. The device "applies personalized gain settings based on user input and fine-tuning. Utilizes NAL-NL2 fitting algorithm."

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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.

2. Sample Size for the Test Set and Data Provenance

• Clinical Validation Study (Test Set):

  • Sample Size: 38 subjects (19 at each clinical site) for the initial in-lab session. 37 subjects for the wear-time field trial.
  • Data Provenance: Two geographically disparate U.S. clinical audiology sites. The study was prospective.

• Usability Testing (Summative Usability Study):

  • Sample Size:
    • 21 participants who were not intended device users (for external packaging and labeling).
    • 15 intended users (i.e., those with mild-moderate hearing loss) for functional usability (setting up earbuds).
  • Data Provenance: Not explicitly stated, but implies U.S.-based given the FDA submission context. Prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Clinical Validation Study (for PRO-FIT comparison): Ground truth for the "PRO-FIT" (professional fitting) condition was established by an audiologist at each clinical site. The description refers to "an audiologist fit the same device using in situ NAL-NL2 real ear aided response (REAR) targets." This implies at least two audiologists (one per site). Their specific qualifications (e.g., years of experience) are not detailed.
• Self-fitting method: The "ground truth" for the self-fitting aspect of the device is based on the NAL-NL2 prescription algorithm, which is a validated and widely used algorithm in audiology.

4. Adjudication Method for the Test Set

• Clinical Validation Study: The clinical study was a cross-over, within-subject (repeated measures) wear-time field trial. Subjects were blinded as to which fitting (SELF-FIT or PRO-FIT) they were wearing during the field trial. This blinding serves as a form of "adjudication" against bias in subjective reporting. For objective measures like REAR and QuickSIN scores, statistical analysis was used to compare the conditions. No explicit "expert panel" style adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, this was not an MRMC study in the traditional sense. MRMC studies are typically for diagnostic imaging where multiple readers interpret cases.
• This was a clinical validation study comparing two fitting methods (self-fit vs. professional-fit) of the same hearing aid device in human subjects. The study assessed the effectiveness of one method (self-fitting) compared to another (professional fitting) and showed non-inferiority for the self-fitting method, not an improvement of human readers with AI assistance.
• Effect Size: The study reported that the SELF-FIT was statistically non-inferior to PRO-FIT for APHAB-global scores and QuickSIN scores. For APHAB-global scores, the mean scores for SELF-FIT and PRO-FIT were "nearly identical," indicating very similar performance. For REAR, while SELF-FIT showed slightly less high-frequency gain than PRO-FIT, it was determined to be "ultimately inconsequential to performance" as evidenced by functional outcomes. The equivalence region for QuickSIN was ±1.5 dB, and equivalence was found within this range.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, in essence, the "SELF-FIT" condition represents a standalone algorithm performance (without professional human intervention). The device self-fits based on user input and the NAL-NL2 algorithm. The clinical study's primary goal was to validate the reliability and effectiveness of this standalone self-fitting method by comparing it to a professionally-fitted version of the same device. The entire field trial evaluated the device being used "without the assistance of a hearing care professional."

7. The Type of Ground Truth Used

• Clinical Validation Study:

  • Expert Consensus/Standard: For the "PRO-FIT" condition, the ground truth was based on a best-practices professional fitting using in situ NAL-NL2 real ear aided response (REAR) targets by an audiologist.
  • Clinical Outcomes Data: For effectiveness endpoints, QuickSIN scores (speech-in-noise test) and APHAB questionnaires (patient-reported outcome of hearing aid benefit) were compared. These are standardized and validated clinical outcome measures reflecting functional performance and patient perception.
  • Objective Measures: REAR measurements were used to objectively assess the acoustic output of the hearing aid in the ear.

• Biocompatibility: In-vitro and in-vivo testing according to ISO 10993 standards (e.g., cytotoxicity, sensitization, intracutaneous reactivity).

• Electroacoustic Performance: Ground truth derived from established industry standards like ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size for the training set used to develop or train the Jabra Enhance Plus's self-fitting algorithm. The "self-fitting method" utilizes the validated NAL-NL2 fitting algorithm, which is an established prescription method in audiology, not typically "trained" on a specific dataset in the way a deep learning model would be. The document states NAL-NL2 is "widely used by hearing care professionals."

9. How the Ground Truth for the Training Set Was Established

• As mentioned above, the device uses the NAL-NL2 fitting algorithm. This algorithm itself is the "ground truth" for how the device determines personalized gain settings based on user input. The document mentions "NAL-NL2 is widely used by hearing care professionals to fit persons with mild to moderate hearing loss." The development and validation of NAL-NL2 as a prescriptive fitting formula involved extensive research and clinical studies by its developers (National Acoustic Laboratories, Australia) over many years, establishing its effectiveness and empirical basis in audiology rather than being a "training set" in the machine learning sense for this specific device. The device's self-fitting procedure then applies this established algorithm.

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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.

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

• Test Set Sample Size:
  • Phase 1 (Quantitative Measures - Audiometric Thresholds & REM): All 80 subjects participated in both self-fitting and audiologist-determined threshold measurements and Real Ear Measurements (REM). This implies 160 ears were tested for the PTA MAD (Figure 2a) and 159 ears for the REM MAD (Figure 3a).
  • Phase 2 (Qualitative Measures - COSI): 80 subjects were randomized (1:1) into two groups: "Audiologist-Fit" (N=40) and "Self-Fit" (N=40). For the COSI analysis, 39-40 subjects per cohort were used (Figure 4a, Figure 4b).
  • Usability Testing: 36 untrained participants.
• Data Provenance: The study was a "prospective, randomized, two-arm, multicenter (4 clinical sites) clinical validation study." The document does not specify the country of origin, but given the FDA submission, it's typically either conducted in the U.S. or under strict international standards acknowledged by the FDA. The nature of the study (prospective) means data was collected specifically for this study under predefined protocols.

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

• Phase 1 Ground Truth: The ground truth for audiometric thresholds and Real Ear Measurements (REM) was established by "a licensed audiologist using a calibrated, clinical audiometer." The study was conducted at "4 clinical sites," implying multiple audiologists, though the exact number isn't specified. The qualification is "licensed audiologist."
• Phase 2 Ground Truth: The "Audiologist-Fit" group in Phase 2 served as a comparative arm, where the device was fit by "a licensed audiologist." The ground truth for user satisfaction (COSI) was based on "participant-reported, adjective-scale" responses, comparing the outcomes of self-fitting with audiologist-fitting.
• Usability Testing Ground Truth: The assessment of critical tasks was moderated, but the "ground truth" for usability seems to be based on participants' successful completion of tasks and their subjective assessments, rather than expert judgment of performance against a predefined "correct" interaction.

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

The document does not describe an explicit adjudication method (like 2+1 or 3+1 with multiple readers/experts) for establishing ground truth in the clinical performance sections. For audiometric and REM measurements, the comparison was directly between the self-fitting method and a single audiologist's measurement. For the COSI scores, it was a comparison of subject-reported outcomes between two fitting strategies.

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

The study was a "two-arm" clinical validation study comparing self-fitting with audiologist-fitting. It was not an MRMC study in the typical sense of evaluating human reader performance with or without AI assistance. Instead, it directly compared a device's self-fitting capability to a professional fitting, both of which result in a device configuration. The "AI" aspect here is the "proprietary fitting algorithm" in the "Braun® ClearCheck™ Hearing Test" within the mobile application that performs the self-fitting. The study does not quantify how much human audiologists improve with AI assistance, but rather shows that the device's self-fitting capability is non-inferior to traditional audiologist fitting.

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

Yes, in a sense. Phase 1 of the study specifically evaluated the "self-fitting hearing test of the BHA100 Series Braun® Clear™ Hearing Aid." This "self-fitting" process is driven by the device's algorithm, with the user interacting with the mobile application rather than a human professional for the fitting process. The comparison was then made against audiologist-determined thresholds, effectively evaluating the algorithm's performance in generating fitting parameters.

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

• Phase 1 Ground Truth:
  • For audiometric thresholds (PTA): "audiologist executed hearing test [...] using a calibrated, clinical audiometer." This is a form of expert measurement/diagnostics, considered the clinical standard.
  • For Real Ear Measurements (REM): Gold standard clinical measurement (NAL-NL2 targets) performed by a licensed audiologist using calibrated equipment.
• Phase 2 Ground Truth:
  • For COSI scores (user satisfaction): "participant-reported, adjective-scale" responses. This is patient-reported outcomes data.
• Safety: Adverse event reporting and adjudication (clinical site PI determined SAE not device-related).
• Non-clinical: Compliance with established international and national standards (e.g., IEC, ISO, ANSI).

8. The sample size for the training set

The document does not specify a separate "training set" sample size for the device's proprietary fitting algorithm. The information provided heavily focuses on the clinical validation study (test set) for the premarket notification. Device algorithms are typically "trained" on large, diverse datasets before clinical validation. This document only describes the performance evaluation of the already trained and implemented algorithm.

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

Since the document does not discuss the training phase of the algorithm, it does not specify how the ground truth for any potential training set was established. However, for a self-fitting hearing aid using a proprietary fitting algorithm (Braun® ClearCheck™ Hearing Test), it's highly probable that the algorithm's development and training (if applicable) would have involved extensive audiometric data established by audiologists, similar to the "ground truth" established by the audiologist-executed tests in Phase 1 of this validation study.

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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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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:

Study Details for Effectiveness (Clinical Validation)

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Phase I Study: 50 adult subjects (49 with mild to severe hearing loss, 1 with normal hearing).
  • Phase II Study: 75 adult subjects with mild to moderately severe hearing loss. These were divided into two groups for the field trial:
    • Pro-Fit Group: 37 subjects
    • Self-Fit Group: 38 subjects
• Data Provenance: The text does not explicitly state the country of origin.
• Study Design:
  • Phase I: Laboratory study, prospective.
  • Phase II: Prospective, two-arm, pre-market study.

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

• Phase I & II (Ground Truth for Professional Fitting): "Several participating licensed audiologists" were used for professional fitting.
  • Qualifications: "Licensed audiologists." No further details on years of experience are provided.

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

• The text describes a comparison between "professionally-selected settings" and "DRC user-selected settings." For establishing the "professionally-selected settings" (which serves as a reference or "ground truth" for comparison to self-fitting), there is no mention of a formal adjudication process (like 2+1 or 3+1) among audiologists who performed the fitting. The implication is that each audiologist applied standard professional fitting practices.
• For the sound quality comparison in the Phase II study, it involved "blind sound quality comparisons conducted in their everyday lives," where subjects compared their own settings to the clinician-selected settings. This is a direct patient preference assessment rather than an expert adjudication of ground truth.

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

• This was not an MRMC comparative effectiveness study involving AI assistance for human readers.
• Instead, it was a comparative effectiveness study comparing human-professional fitting (Pro-Fit Group) vs. user self-fitting (Self-Fit Group) using AI/device-based algorithms (DRCs) without professional assistance.
• The effect sizes reported are on the effectiveness of the self-fitting method compared to professional fitting:
  • Sound Quality Preference (Phase II): Subjects in the Self-Fit Group preferred their own settings over clinician-selected settings "significantly (p < 0.0001) more." (Figure 5a shows a clear shift in distribution towards preferring "Self-Fit" in the Self-Fit group vs. "No Pref" or slight "Pref Clin" in the Pro-Fit group).
  • Satisfaction with Sound Quality (Phase II): Self-Fit group rated themselves "significantly happier with the sound quality" (p < 0.0001). (Figure 5b shows a higher proportion of 4 and 5-star ratings for the Self-Fit group).
  • Speech-in-Noise Recognition (QuickSIN - Phase II): The QuickSIN benefit scores in the Self-Fit Group were "significantly non-inferior" to those of the Pro-Fit Group (p < 0.05). This means there was no statistically significant reduction in benefit when self-fitting compared to professional fitting.
  • Patient-Reported Outcomes (APHAB & SSQ-12 - Phase II): Benefit experienced by the Self-Fit Group was "significantly non-inferior" to the Pro-Fit Group (p < 0.05) for both global and subscale scores. Again, indicating no significant reduction in benefit.
  • Gain Settings (Phase II): Subject-selected gain was "significantly correlated" with professionally-selected gain (r = 0.65, p < 0.0001) and was on average only 1.9 dB less than professionally-fit gain. This quantifies the similarity of the user-derived settings to professional ones.

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

• The "Self-Fit" group in the Phase II study effectively represents the "algorithm only" performance as used by a lay human without professional assistance. The user manipulates the "Dimension-Reduced Controllers (DRCs)" (Loudness and Fine Tuning) which are implemented by the device's algorithms. The core of the study is validating the effectiveness of this self-fitting strategy.
• The Phase I study specifically evaluated the "validity of the DRC method for user self-fitting of signal processing parameters" with a simulated hearing aid. The "ground truth" here was the NAL-NL2 prescriptive gain. This part of the study could be considered akin to a standalone algorithm evaluation, as it assessed how closely user-selected gains via the DRCs matched a conventional prescriptive target.

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

• For Electroacoustic and Mechanical bench testing: Ground truth was established by adherence to established industry standards (e.g., ANSI S3.22, ANSI/CTA 2051, IEC standards).
• For Biocompatibility: Ground truth was established by adherence to ISO 10993-1 and specific biological testing (cytotoxicity, irritation, skin sensitization) with defined pass/fail criteria.
• For Self-Fitting Effectiveness (Clinical Studies):
  • Reference/Comparator Ground Truth: "Professionally-selected settings" by licensed audiologists using a "custom professional fitting application." This essentially serves as an expert-derived ground truth for optimal fitting.
  • Clinical Effectiveness Measures: Standardized objective tests (QuickSIN for speech-in-noise) and validated patient-reported outcome measures (APHAB, SSQ-12 questionnaires) as well as patient subjective preferences and sound quality ratings.
  • Phase I specific: Comparison to NAL-NL2 prescriptive gain as a target for "validity."

8. The sample size for the training set

• The document does not provide details on a specific "training set" sample size for the development of the self-fitting algorithms (DRCs). This is common for regulatory submissions where the focus is on validation rather than the internal development process. The algorithms (DRCs) themselves are the result of Bose's R&D, likely incorporating internal data and audiometric principles, but a distinct "training set" for the algorithm's development and its sample size is not presented in this regulatory summary.

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

• As the document does not detail a specific "training set" for the AI/algorithm development, it also does not explain how ground truth for such a set was established.
• However, the Phase I study provides insight into the validation of the self-fitting method, showing that "the average deviation from NAL-NL2 prescribed gain for subject-selected gain was 5 dB, which was in line with published reports of preferred gain settings after post-fitting fine tuning." This suggests that NAL-NL2 prescriptive targets and published reports on preferred gain settings served as a key reference or "ground truth" during the development and validation of the DRCs' effectiveness in achieving appropriate gain settings. The DRCs essentially aim to allow users to approximate these audiologically sound targets without professional intervention.

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