(30 days)
A. General Indications: 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)): Serverity: 1. Slight 2. Mild X 3. Moderate X 4. Severe X 5. Profound Configuration: 1. High Frequency - Precipitously sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low tolerance to loudness 2. 3. B. Specific Indications (Only if appropriate.): 1. psychoacoustic indications such as improved speech (Most intelligibility in background noise, must be supported by clinical data.) 2. 3.
RION HB-79P
The provided document is a 510(k) clearance letter for the Rionet HB-79P hearing aid. It is a regulatory document affirming substantial equivalence to a predicate device, rather than a study report detailing performance against acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details of a standalone algorithm-only performance study.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
The document indicates that the device's indication for use is "to amplify sound for individuals with impaired hearing" within specific severity and configuration categories of hearing loss (e.g., Moderate, Severe, Profound, Gradually Sloping, Reverse Slope, Flat). However, these are indications for use and not performance acceptance criteria against which a study measured the device. The only mention of "clinical data" is for "psychoacoustic indications such as improved speech intelligibility in background noise," but no such data or study is presented or summarized in this regulatory letter.
§ 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.