(34 days)
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
Configuration:
✔ 1. High Frequency - Precipitously Sloping
✔ 2. Gradually Sloping
✔ 3. Reverse Slope
✔ 4. Flat
Other
✔ 1. Low tolerance To Loudness
Not Found
This document is a 510(k) clearance letter for a hearing aid, not a study report or clinical trial. Therefore, it does not contain the detailed information about acceptance criteria, study design, and performance metrics that you requested.
Specifically, the document:
- Does not outline acceptance criteria or reported device performance in a table. The letter indicates the device is "substantially equivalent" to previously marketed devices, implying it meets existing standards for hearing aids but doesn't detail performance metrics.
- Does not provide information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These elements are typical of clinical studies (especially for AI/ML devices) but are not relevant to a 510(k) clearance based on substantial equivalence to a predicate device. The letter for this device is from 1997, well before the widespread use of AI/ML in medical devices and the associated rigorous evaluation requirements.
Summary of available information related to your request (though limited):
- Device Name: Ovation HDP Air Conduction Hearing Aid
- Regulatory Class: I, 21 CFR 874.3300/Procode: 77 ESD
- Indications for Use: To amplify sound for individuals with impaired hearing.
- Severity: Slight, Mild, Moderate, Severe (not Profound)
- Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
- Other: Low tolerance To Loudness
- Basis for Clearance: Substantial equivalence to devices marketed prior to May 28, 1976. This means the device was benchmarked against existing hearing aids, not necessarily through new, specific performance studies as would be required today for novel devices or AI/ML.
In conclusion, this document cannot fulfill your request for detailed acceptance criteria and study information because it is an FDA clearance letter based on substantial equivalence, not a clinical study report.
§ 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.