(85 days)
Not Found
No
The device description focuses on standard hearing aid components and configurations, with no mention of AI or ML technologies.
No
The device is a hearing aid designed to amplify sound for individuals with impaired hearing, which is a compensatory or assistive function rather than a therapeutic one. It does not treat, cure, or prevent a disease or condition.
No
This device is described as an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." Its function is to assist hearing, not to diagnose a condition.
No
The device description clearly describes a physical hearing aid that fits in the ear canal, uses a battery, and has physical components like a volume control and circuits. It does not describe software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals with impaired hearing." This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The description details a hearing aid designed to fit in the ear canal and amplify sound. It focuses on physical characteristics and sound processing, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device is a hearing aid, which is a medical device used to improve hearing, not to diagnose or analyze biological samples.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
- 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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Flat
Other: Low tolerance to loudness
Product codes
77 ESD
Device Description
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. Preliminary data sheets from the CIC V-38 models are enclosed. Dispenser controlled Volume Control. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN - 6 1997
ﺎ
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name: | Vista Labs 409 S. Tower, Centralia, WA 98531 | |||||
|---|---|---|---|---|---|---|
| Owner: James E. Pannette | ||||||
| Establishment 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 equivalent | |||||
| to 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 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. | ||||||
| Assembly: | Assembled from standard components which are widely utilized by | |||||
| other hearing aid manufacturers. | ||||||
| Technical Characteristics: | Technical specifications comply with S3.22-1987 ANSI | |||||
| Specifications. Preliminary data sheets from the CIC V-38 | ||||||
| models are enclosed. | ||||||
| Controls: | Dispenser controlled Volume Control. | |||||
| Fit: | The frequency response of this product is dictated by the | |||||
| individual audiogram from each client. | ||||||
| Power: | Standard hearing aid battery. |
A user's manual and other information is supplied with each hearing aid (enclosed).
.
1
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.
2
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
3
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 Frequency | |||
| Precipitously Sloping | 1. | X | Low tolerance to | |||||
| loudness | ||||||||
| 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.)
-
- 3