(88 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:
X 1. Slight
X 2. Mild
X 3. Moderate
X 4. Severe
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
Other
X 1. Low tolerance To Loudness
To amplify and transmit sound to the ear.
Assembled from standard components which are widely utilized by other hearing aid manufacturers.
The frequency response of this product is dictated by the individual audiogram from each client.
Standard hearing aid battery.
A user's manual and other information is supplied with each hearing aid.
The provided text does not contain any information about acceptance criteria, device performance results from a study, or details of a study methodology.
The document is a US FDA 510(k) clearance letter for Heartland Technologies' ITE, ITC, and CIC hearing aids, dated August 15, 1997. It declares the device "substantially equivalent" to legally marketed predicate devices, allowing its commercialization.
The letter mentions:
- Intended Use: "To amplify and transmit sound to the ear."
- Technical Characteristics: "Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications."
- Fit: "The frequency response of this product is dictated by the individual audiogram from each client."
- Indications for Use: General indications for individuals with impaired hearing across various severity levels (slight, mild, moderate, severe), configurations (high frequency - precipitously sloping, gradually sloping, reverse slope, flat), and "Low tolerance To Loudness."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details because it is not present in the provided text. The letter primarily focuses on regulatory clearance based on substantial equivalence, not on the detailed results of a performance study against specific acceptance criteria.
§ 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.