(85 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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Flat
Other: Low tolerance to loudness
The Vista completely in the canal (CIC) is a small instrument designed to fit competely in the ear canal. The volume control is a standard screw-set control and uses a #10A or 5A battery. The CIC fit reduces residual ear canal volume and results in the need for less gain, decreased chance of feedback, improvement of high frequency gain, decreased occlusion effect, and lesser self-masking. The CIC's circuits are assembled into a variety of different configurations including Class D, K-amp, and RGA Class A. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. Dispenser controlled Volume Control. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
The provided document is a 510(k) premarket notification for a hearing aid, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims.
As such, the document does not contain the acceptance criteria or a study demonstrating the device meets performance criteria in the way a typical clinical trial for a new medical device would. Instead, the criteria outlined are related to technical specifications and intended use, and the "study" is a demonstration of compliance with existing standards and substantial equivalence.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established through Substantial Equivalence and ANSI Standards) | Reported Device Performance |
|---|---|
| Intended Use: To amplify and transmit sound to the ear. | The device is a "Completely In The Canal (CIC) V-38 Hearing Aid" designed for this purpose. The 510(k) approval confirms it's substantially equivalent for this intended use. |
| Technical Characteristics: Comply with S3.22-1987 ANSI Specifications. | "Technical specifications comply with S3.22-1987 ANSI Specifications. Preliminary data sheets from the CIC V-38 models are enclosed." (The actual data sheets are not provided in this excerpt, but their compliance is stated.) |
| Fit/Frequency Response: Dictated by the individual audiogram from each client. | The device is designed to fit completely in the ear canal. Its frequency response is customizable based on the client's audiogram. Features like reduced residual ear canal volume, decreased feedback chance, improvement of high-frequency gain, decreased occlusion effect, and lesser self-masking are cited as benefits of the CIC fit. |
| Assembly: Assembled from standard components widely utilized by other hearing aid manufacturers. | "Assembled from standard components which are widely utilized by other hearing aid manufacturers." |
| Indications for Use: Amplify sound for individuals with impaired hearing. Categories include: Slight, Mild, Moderate, Severe hearing loss; High Frequency Precipitously Sloping, Flat configurations; Low tolerance to loudness. | The FDA letter acknowledges the "indications for use stated in the enclosure" (which is the filled-out form indicating these categories). The substantial equivalence determination allows the device to be marketed for these indications. |
Missing Information: It's crucial to note that for a hearing aid, typical performance metrics would include aspects like gain, output, frequency response accuracy, distortion, battery life, and possibly specific psychoacoustic measures (e.g., speech intelligibility for specific scenarios if specific claims were made). The document only states compliance with ANSI S3.22-1987, which would cover many of these. The exact numerical performance values against specific ANSI tolerances are not presented in this document.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission, which relies on substantial equivalence to a predicate device, rather than a de novo clinical study with a "test set" in the traditional sense of evaluating device performance on patients.
- Sample Size: Not applicable in the context of a prospective clinical "test set" with patient data. The "sample" here refers to the device itself and its technical specifications compared against established standards and a predicate device.
- Data Provenance: The data provenance is primarily the technical specifications of the Vista V-38 CIC Hearing Aid itself, which are affirmed to comply with ANSI S3.22-1987. No patient-specific or clinical trial data is presented in this excerpt. The submission is based on the device's design, components, and stated compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not directly applicable to this type of submission. The "ground truth" for a 510(k) is often established by the predicate device's existing market acceptance and regulatory clearance, as well as by industry standards (like ANSI S3.22-1987) that expert committees have developed and approved.
- Qualifications of Experts: The experts involved in establishing the ANSI standards would be acousticians, audiologists, engineers, and other specialists in hearing aid technology. The FDA reviewers (e.g., Lillian Yin, Ph.D., Director of the relevant division) are the regulatory experts who determine if the submission adequately demonstrates substantial equivalence.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" of patient data that requires expert adjudication. The process is a regulatory review by the FDA based on the submitted technical documentation and comparison to a predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Vista V-38 CIC is a medical device (hearing aid), not an AI-powered diagnostic or assistive technology in the modern sense that would require such a study for its 510(k) clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, a standalone performance study was not done. This concept primarily applies to AI/ML algorithms. The Vista V-38 CIC is a hardware device with specific electronic circuits ("Class D, K-amp, and RGA Class A"); its performance is inherent to its design and manufacturing, not an algorithm that operates independently.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is primarily:
- Predicate Device Performance: The demonstrated safety and effectiveness of the legally marketed predicate device(s) that the Vista V-38 CIC claims substantial equivalence to.
- Industry Standards: Compliance with recognized consensus standards, specifically ANSI S3.22-1987 for hearing aid specifications.
- General Medical Understanding: The accepted medical understanding of hearing loss and the function of hearing aids (e.g., "to amplify sound for individuals with impaired hearing").
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI/ML algorithm development. This is a traditional medical device (hearing aid). The "training" for such a device would be the engineering and design validation process using standard components and established manufacturing practices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an AI/ML algorithm, there's no ground truth established for it. The "ground truth" (or basis of performance and safety) for a traditional medical device like a hearing aid is established through adherence to engineering principles, relevant national/international standards, and manufacturing quality controls.
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JUN - 6 1997
ﺎ
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name: | Vista Labs 409 S. Tower, Centralia, WA 98531 | |||||
|---|---|---|---|---|---|---|
| Owner: James E. PannetteEstablishment Registration Number: 3025260 | ||||||
| 510(k) Number: K970939 | ||||||
| Name of Device: | Vista Completly In The Canal (CIC) V-38 Hearing Aid | |||||
| Type of Device: | In the Canal Air Conduction Hearing Aid - Substantially equivalentto other In the Canal Air Conduction hearing aids. | |||||
| Intended Use: | To amplify and transmit sound to the ear. | |||||
| Features: | The Vista completely in the canal (CIC) is a small instrumentdesigned to fit competely in the ear canal. The volume control is a'standard screw-set control and uses a #10A or 5A battery. TheCIC fit reduces residual ear canal volume and results in the need forless gain, decreased chance of feedback, improvement of highfrequency gain, decreased occlusion effect, and lesser self-masking.The CIC's circuits are assembled into a variety of differentconfigurations including Class D, K-amp, and RGA Class A. | |||||
| Assembly: | Assembled from standard components which are widely utilized byother hearing aid manufacturers. | |||||
| Technical Characteristics: | Technical specifications comply with S3.22-1987 ANSISpecifications. Preliminary data sheets from the CIC V-38models are enclosed. | |||||
| Controls: | Dispenser controlled Volume Control. | |||||
| Fit: | The frequency response of this product is dictated by theindividual audiogram from each client. | |||||
| Power: | Standard hearing aid battery. |
A user's manual and other information is supplied with each hearing aid (enclosed).
.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Randy L. Bishop Director of Audiology Vista Labs 409 South Tower Centralia, WA 98531 Re: K970939
VISTA V-38 CIC Hearing Aid Dated: February 17, 1997 Received: March 13, 1997 ... Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Bishop:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources, is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing gid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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24 '97 02:43PM P.3/4
K970939 510 (k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________ Vista V-38 CIC
Indications for Use:
- General Indications: A.
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 | Configuration | Other | ||||||
|---|---|---|---|---|---|---|---|---|
| 1. | X | Slight | 1. | X | High FrequencyPrecipitously Sloping | 1. | X | Low tolerance toloudness |
| 2. | X | Mild | 2. | Gradually Sloping | 2. | |||
| 3. | X | Moderate | 3. | Reverse Slope | 3. | |||
| 4. | X | Severe | 4. | X | Flat | |||
| 5. | Profound | 5. | Other |
B. Specific Indications (Only if Appropriate.)
(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
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§ 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.