(102 days)
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Finetone ITE Faceplate Assembly, Model M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls.
Finetone ITE Faceplate Assembly, Model M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls.
Finetone ITE Faceplate Assembly, Model M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls.
Finetone ITE Faceplate Assembly, Model M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls.
Finetone ITE Faceplate Assembly, Model M-KAMP detects and amplifies quiet sounds. In loud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls.
Finetone ITE Faceplate Assembly, Model M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls.
I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for Finetone ITE Faceplate Assembly Aid Models. It outlines the regulatory classification and general indications for use for several hearing aid models (M-LIN, M-H LIN, M-D, M-PP, M-D/ASP, M-D/AGCI, M-K-6AMP, and M-EQII).
This document does not contain any information regarding acceptance criteria for device performance, details of a study (like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details), or the type of ground truth used.
The document primarily focuses on:
- The FDA's determination of substantial equivalence to previously marketed devices.
- General controls provisions of the Act that apply.
- A warning about potential electromagnetic interference from digital cellular telephones and the encouragement to modify device labeling accordingly.
- An explanation of when a 510(k) submission would be required for claims related to electromagnetic compatibility.
- General indications for use for each model, specifying the severity, configuration, and tolerance of hearing loss they are intended to address. For example, for the M-LIN, it indicates "Slight, Mild, Moderate" severity, "High frequency Precipitously sloping, Gradually sloping, Flat" configuration, and "Normal Tolerance."
Therefore, I cannot fulfill your request for details about acceptance criteria and a study proving their fulfillment as this information is not present in the provided text.
§ 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.