(14 days)
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Not Found
No
The device description focuses on standard hearing aid components, battery life, and fitting based on audiograms. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is a hearing aid, which is used to amplify sound for individuals with impaired hearing, addressing a medical condition (hearing loss), thus making it a therapeutic device.
No
This device is described as an "air conduction hearing aid" intended "to amplify sound for individuals with impaired hearing." Its function is to modify sound to assist hearing, not to diagnose a medical condition.
No
The device description explicitly states it is an "ITE Hearing Aid" and details hardware components like a battery, assembly from standard components, and technical characteristics related to physical performance. This indicates it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an air conduction hearing aid. Its purpose is to amplify sound for individuals with impaired hearing. This is a therapeutic and assistive device, not a diagnostic test performed on a biological sample.
- Lack of Diagnostic Activity: The description focuses on the technical characteristics of the hearing aid itself (battery size, assembly, frequency response based on audiogram) and its intended use for hearing amplification. There is no mention of analyzing biological samples or providing diagnostic information about a disease or condition.
Therefore, based on the provided information, this device falls under the category of a medical device for hearing assistance, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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):
Severity:
- Slight
- Mild
- Moderate
- Severe
Configuration: - High Frequency - Precipitously Sloping
- Gradually Sloping
- Reverse Slope
- Flat
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
Name of Device: Vista V-12 Long Life 675 Class D
Type of Device: ITE Hearing Aid - substantially equivalent to other in-the-ear (ITE) hearing aids.
Features: 675 Long Life battery using a 675 size battery pill in an ITE Hearing Aid, with Class D battery size gives the benefit of extended battery life for this style of hearing instrument.
Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers.
Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications Preliminary data sheets for the Vista V-12 Long Life models are enclosed
Fit: The frequency response of this product is dictated by the individual audiogram from each client.
Power: Standard 675 size hearing aid battery.
A user's manual and other information is supplied with each hearing aid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG -5 1997
K972755
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Vista V-12 Long Life 675 Class D |
|---|---|
| Type of Device: | ITE Hearing Aid - substantially equivalent to other in-the-ear (ITE) hearing aids. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Features: | 675 Long Life battery using a 675 size battery pill in an ITE Hearing Aid, with Class D battery size gives the benefit of extended battery life for this style of hearing instrument. |
| Assembly: | Assembled from standard components which are widely utilized by other hearing aid manufacturers. |
| Technical Characteristics: | Technical specifications were obtained in accordance with |
| S3.22-1987 ANSI Specifications | |
| Preliminary data sheets for the Vista V-12 Long Life models are enclosed | |
| Fit: | The frequency response of this product is dictated by the individual audiogram from each client. |
| Power: | Standard 675 size hearing aid battery. |
| A user's manual and other information is supplied with each hearing aid. |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird image. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1997
ﺐ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Randy L. Bishop Director of Audiology Vista Labs 409 S. Tower Centralia, WA 98531
Re: K972755 V-12 Long Life 675 Hearing Aid Dated: January 1, 1997 Received: July 22, 1997
21 CFR 874.3300/Procode: 77 ESD
Regulatory class: I
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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 decord substantially equivalent to other legally marketed hearing aids, please be advised that clectromagnetic interference from digital celluiar 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 aid temporariiy 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 infer that your device is compatible with potential sources of clectromagnetic 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 and additionally 809.10 for in vitro diagnostic devices), 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
holliam Yi
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
510(k) Number (if known):
Device Name: V-12 Long Life 675
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to -------ainplify sound for individuals with impaired hearing. The devices are indicated " iii 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. Slight | ✓ 1. High Frequency |
- Precipitously Sloping | ___ 1. Low tolerance To Loudness |
| ✓ 2. Mild | ✓ 2. Gradually Sloping | ___ |
| ✓ 3. Moderate | ✓ 3. Reverse Slope | ___ |
| ✓ 4. Severe | ✓ 4. 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.)
Image /page/3/Figure/7 description: The image shows a list of numbers 1, 2, and 3 on the left side of the image. A curved line is drawn from the top left of the image and extends diagonally down towards the bottom center. The background is white. The numbers are vertically stacked.
(PLE.A.SE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED).
| Concurrence of SDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K972755 |
|---|---|
| --------------- | --------- |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)