(56 days)
To assist in conversation, meetings and TV-listening by amplifying sound.
The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies).
Severity: Mild, Moderate
Configuration: Gradually Sloping, Flat
Air Conduction Assistive Listening Device. Personal Amplifier.
Features: Adjustable volume control, Microphone/Telephone/Off switch, Gain, Treble and AGC adjustment trimmers, Internal/External microphone switch.
Assembly: Assembled from standard components widely used in electronic products.
Technical Characteristics: Technical specifications comply with ANSI S3.22-1987.
Controls: Volume control, Microphone/Telephone/Off switch, Internal/External microphone switch and sound adjustment trimmers similar to those used on other assistive listening devices/Personal amplifiers.
Power: Standard alkaline AAA (or LR03) size battery.
Here's an analysis of the provided text to extract the requested information about the Bellman Response model 1050:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Technical Characteristics) | Reported Device Performance |
|---|---|
| Complies with ANSI S3.22-1987 | Technical specifications comply with ANSI S3.22-1987 |
| Adjustable volume control | Adjustable volume control |
| Microphone/Telephone/Off switch | Microphone/Telephone/Off switch |
| Gain, Treble and AGC adjustment trimmers | Gain, Treble and AGC adjustment trimmers |
| Internal/External microphone switch | Internal/External microphone switch |
| Power: Standard alkaline AAA (or LR03) size battery | Standard alkaline AAA (or LR03) size battery |
| Controls similar to other assistive listening devices/personal amplifiers | Controls similar to those used on other assistive listening devices/Personal amplifiers |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) for a study to prove the device meets acceptance criteria. The document appears to be focused on a 510(k) premarket notification for substantial equivalence, which often relies on comparison to predicate devices and technical standards rather than new clinical trials with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no specific clinical study with a test set and ground truth establishment is described, there's no information about experts or their qualifications.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI Assistance
Not applicable. This device is an analog assistive listening device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. The Bellman Response model 1050 is an assistive listening device, not an algorithm. Its performance is inherent in its hardware and amplification capabilities, not in a standalone algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of a typical clinical study requiring ground truth. The "ground truth" for this device's performance relies on its adherence to technical specifications (ANSI S3.22-1987) and its ability to amplify sound, rather than on expert consensus, pathology, or outcomes data from a clinical trial. The basis for its approval is substantial equivalence to legally marketed predicate devices, implying that their "ground truth" performance and safety were already established.
8. The Sample Size for the Training Set
Not applicable. This device is hardware for audio amplification. There is no concept of a "training set" as understood in machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, no ground truth was established for it.
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.