(79 days)
The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss.
The Model Alpha is a linear hearing device. The electronics for this hearing instrument are contained in a custom acrylic plastic case. The device has one user control - the volume wheel, and no potentiometers. The device does not require any special fitting systems.
The acoustical output of the Ototech Model Alpha is a maximum SSPL90 of 122 dB SPL (ANSI S3.22, 1987). The reference test gain is 43 dB SPL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ototech International Model Alpha Behind-The-Ear Hearing Instruments:
Based on the provided 510(k) summary, this submission is for a hearing aid, a device with well-established performance standards. The "study" referenced here is the evaluation of the device's technical specifications against an industry standard (ANSI S3.22-1987) and comparison to predicate devices, rather than a clinical study evaluating diagnostic accuracy or a human-in-the-loop scenario.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ANSI S3.22-1987 standard for hearing aids and the characteristics of the predicate devices. The reported device performance is directly from the technical specifications.
| Acceptance Criterion | Reported Device Performance (Ototech Alpha) |
|---|---|
| Acoustical Output (Max SSPL90) | Max 122 dB SPL (ANSI S3.22-1987) |
| HF Average SSPL90 | 121 dB SPL |
| HF Average Full-on Gain | 50 dB SPL |
| Reference Test Gain | 43 dB SPL |
| Equivalent Input Noise | 25 dB SPL |
| Frequency Range | 200-5800 Hz |
| Total Harmonic Distortion (THD) at 500 Hz | 5% |
| Total Harmonic Distortion (THD) at 800 Hz | 5% |
| Total Harmonic Distortion (THD) at 1600 Hz | 3% |
| Battery Size | 675 |
| Battery Type | Zinc-Air |
| Battery Current Drain | 0.9 mA |
| Typical Battery Life | 600 hours |
| Comparison to Predicate Devices (Implied Acceptance) | Max output (122 dB SPL) falls within predicate range (118 to 127 dB SPL). Gain (43 dB SPL) falls within predicate range (33 to 45 dB SPL). |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes technical device specifications and comparison to predicate devices, not a clinical "test set" in the sense of patient data. Therefore, there is no sample size of patients mentioned. The "test set" would be the device itself, evaluated in a laboratory setting according to ANSI standards.
- Sample Size (devices tested): Not explicitly stated, but typically a representative sample of devices would be tested, or a single device's specifications would be presented as representative of the model.
- Data Provenance: The data is technical performance data derived from laboratory measurements of the device itself, adhering to the ANSI S3.22-1987 standard. There is no mention of country of origin of data or retrospective/prospective nature as this is not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of submission does not involve "experts" establishing a ground truth in the context of diagnostic accuracy. The ground truth here is the objective, measurable performance of the hearing aid as defined by the ANSI standard.
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable. There is no subjective interpretation or adjudication involved in measuring the physical and electrical characteristics of the hearing aid against a standard. The measurements are objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of a diagnostic tool on human reader performance, typically in interpreting images or other complex data. This submission is for a hearing aid, whose performance is measured by its acoustical and electrical properties, not by human interpretation of its output in a diagnostic context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The presented data is the standalone performance of the device (the "algorithm" in a broad sense, referring to the device's inherent functional characteristics) without human intervention in its measurement. The measurements (SSPL90, gain, THD, etc.) are objective tests of the device's technical specifications.
7. The Type of Ground Truth Used
The ground truth used is objective engineering specifications and industry standards. Specifically, the device's performance metrics are compared against:
- The requirements and measurement methodologies defined by ANSI S3.22-1987.
- The established technical characteristics of predicate devices (Starkey SM PC, Starkey SM Vega, Bosch Star 22).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data. The device's acoustic and electrical properties are inherent to its design and manufacturing, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.