Search Results

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Other Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other 1. Low tolerance To Loudness

BETTER HEARING, INC. model C-1 Hearing Aid, Type: Behind-The-Ear (BTE), Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery

This document is a 510(k) summary for the BETTER HEARING, INC. Model C-1 Hearing Aid. It confirms substantial equivalence to other devices rather than presenting a study to prove meeting acceptance criteria in the way a clinical trial for a novel device would. Therefore, most of the requested fields are not applicable (N/A) as this is a premarket notification for a Class I device and not a clinical study report.

However, based on the provided text, here's what can be extracted and inferred:

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

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

• Sample Size for Test Set: N/A (No specific test set or clinical study described in detail for performance evaluation beyond compliance with a standard.)
• Data Provenance: N/A (The document focuses on regulatory compliance and substantial equivalence, not a clinical study with geographic or temporal data origin.)

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

• N/A (No ground truth established by experts for a test set is discussed in this regulatory summary.)

4. Adjudication method for the test set

• N/A (No test set or adjudication method is described.)

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

• N/A (This device is a hearing aid, not an AI-powered diagnostic device. No MRMC study was performed.)

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

• N/A (Not an AI algorithm.)

7. The type of ground truth used

• N/A (The "ground truth" here is the regulatory standard of substantial equivalence and compliance with ANSI S3.22 1987, rather than a clinical ground truth for a diagnostic task.)

8. The sample size for the training set

• N/A (Not an AI device; no training set in the AI sense.)

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

• N/A (Not an AI device; no training set in the AI sense.)

Ask a specific question about this device

To amplify and transmit sound to the ear. The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies): Severity: Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Other. Other: Low tolerance To Loudness.

BETTER HEARING, INC. model L-1 Hearing Aid. Type: Behind-The-Ear (BTE). Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery.

Based on the provided text, the "Better Hearing, Inc. Model L-1 Hearing Aid" is a relatively simple device, and the submission document primarily focuses on its substantial equivalence to existing devices rather than a detailed study for novel performance claims. Therefore, much of the requested information (like expert ground truth, MRMC studies, training set details) is not applicable or not provided.

Here's an analysis of the available information:

Description of the Device and its Primary Claim:

The device is a "Behind-The-Ear (BTE)" hearing aid whose "Intended Use: To amplify and transmit sound to the ear." Its classification is "Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300."

A specific claim made by the manufacturer was its "compatibility with digital cellular telephones."

Acceptance Criteria and Reported Device Performance

The FDA did not accept the claim of compatibility with digital cellular telephones. Therefore, there are no reported device performance metrics for this specific claim that met acceptance criteria in this document.

Study Details Related to the "Compatibility with digital cellular telephones" Claim:

The FDA explicitly states that "inadequate EMC test data" was submitted for this claim. This implies some testing was done by the manufacturer, but it did not meet the FDA's criteria for substantiation.

Since the claim was rejected, the following details pertain to the unaccepted study or data:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "inadequate EMC test data," suggesting internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. For an EMC claim, ground truth would typically be established by standardized measurement protocols rather than expert consensus on subjective interpretation.
4. Adjudication method for the test set: Not applicable/not specified. EMC testing would involve objective measurements against a standard, not expert adjudication in the typical sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for an electromagnetic compatibility claim.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. EMC testing is a standalone objective measurement of the device's interaction with electromagnetic fields.
7. The type of ground truth used: Implied to be objective measurements against an electromagnetic compatibility standard (though the specific standard, beyond "inadequate EMC test data," is not detailed).
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary of FDA's Position:

The FDA determined the Model L-1 Hearing Aid was substantially equivalent to predicate devices for its primary function as a hearing aid. However, its specific claim of "compatibility with digital cellular telephones" was not accepted due to insufficient data. The FDA offered to work with Better Hearing, Inc. to develop a testing protocol to substantiate an appropriate claim for EMC.

Ask a specific question about this device