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This device is an audiometer, Audiometers are used by hearing health professionals to conduct diagnostic hearing evaluation and assisting in the diagnostic of possible otologic disorders. It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

It is an electroacoustic device that produce controlled levels of test tones and signals intended for testing the hearing.

This request cannot be fulfilled. The provided text is a truncated FDA 510(k) clearance letter for an audiometer. It does not contain any information regarding acceptance criteria, study design, or performance data for the device. Therefore, I cannot extract the requested information to describe the acceptance criteria and the study that proves the device meets them.

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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)): Severity: 1. Slight 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping 2. Gradually Sloping 3. Reverse Slope 4. Flat 5. Other Other 1. Low tolerance To Loudness 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. 2. 3.

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The provided text is a 510(k) clearance letter from the FDA for two hearing aid devices, the Audiofon H20 PC and H32 PP. This document does not contain the information requested in the prompt regarding acceptance criteria, study data, or ground truth establishment.

The document primarily focuses on:

• FDA's determination of substantial equivalence: It states that the devices are substantially equivalent to pre-amendment devices, allowing them to be marketed.
• Regulatory classification and general controls: It outlines the regulatory class (Class I), applicable CFR parts, and requirements like annual registration, good manufacturing practices, and labeling.
• Indications for Use: It provides a general statement that the devices "amplify sound for individuals with impaired hearing" and allows the manufacturer to check specific severity and configuration categories of hearing loss for which the devices are indicated.

Therefore, I cannot extract the requested information from the provided text. The information typically sought for acceptance criteria and study details would be found within the 510(k) submission itself, often in a separate section detailing performance testing or clinical studies. This letter is the FDA's response to that submission, not the submission itself.

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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: Moderate
Configuration: 1- TWIST PP AGC-1 1. High Frequency - Precipitously Sloping; TWIST PR. Flat
Other: TWIST PP AGC-1 1. Low tolerance To Loudness

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I am sorry, but the provided text does not contain the information needed to fill out the table and answer the questions about acceptance criteria and study details. The document is an FDA 510(k) clearance letter for two hearing aid devices (TWIST PP and TWIST PP AGC-1) from 1997. It primarily discusses regulatory classification, substantial equivalence, and general controls, along with a brief section on electromagnetic interference and labeling.

It does not include:

• Specific acceptance criteria for device performance (e.g., in terms of sensitivity, specificity, accuracy).
• Details of any study conducted to prove the device meets acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states that the devices are for "amplifying sound for individuals with impaired hearing" and specifies general indications related to severity (moderate) and configuration (high frequency - precipitously sloping for TWIST PP AGC-1, and flat for TWIST PP) of hearing loss, as well as low tolerance to loudness for TWIST PP AGC-1. However, these are indications for use, not performance acceptance criteria or study results.

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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)):
Severity: Severe
Configuration: Flat
Other: Low tolerance To Loudness; JAZZ PP AGC-C

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a hearing aid device (Jazz PP AGC-C, Jazz PP) and focuses on substantial equivalence to a predicate device.

It includes:

• Regulatory information: Device name, 510(k) number, regulatory class, procode, and the date of clearance.
• Substantial equivalence determination: The FDA's finding that the device is substantially equivalent to pre-amendments devices.
• General controls provisions: A reminder of requirements like registration, listing, GMP, labeling, and prohibitions against misbranding/adulteration.
• Warnings/Recommendations: Advice regarding electromagnetic interference from cellular phones and the need for possible future testing or labeling modifications.
• Indications for Use: A description of the general and specific indications for which the hearing aid is intended (to amplify sound for individuals with impaired hearing, specifying severity and configuration of hearing loss).

There is no mention of specific acceptance criteria (e.g., performance metrics, thresholds), a study design, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or whether a standalone or MRMC study was conducted.

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