(21 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is a hearing aid, which amplifies sound for individuals with impaired hearing, thereby alleviating and compensating for a diseased or injured condition (hearing loss).
No
The document describes hearing aids, which amplify sound for individuals with hearing impairment. This is a therapeutic or assistive device, not a diagnostic one that identifies or characterizes a medical condition.
No
The intended use clearly describes "air conduction hearing aids," which are hardware devices that amplify sound. The summary does not mention any software-only component or function.
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 ability" using air conduction hearing aids. This describes a device that modifies sound and delivers it to the ear, which is a physical intervention, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- 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.
The device described is a hearing aid, which is a medical device used to treat hearing loss by amplifying sound. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A. General Indications: The indication for use of the air conduction hearing aids in this the indication for abily sound for individuals with impaired Submission 13 co capices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Slight ✓ Mild ✓ Moderate ✓ Severe ✓ Profound Configuration: High Frequency - Precipitously Sloping ✓ Gradually Sloping ✓ Reverse Slope ✓ Flat Other Other Low tolerance To Loudness ✓
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction
Product codes
77 ESD
Device Description
DigiSound Compact
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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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.
0
Image /page/0/Picture/0 description: The image shows a black and white seal for the Department of Health & Human Services USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three curved lines, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Proben Brunved Oticon, Inc. 29 Schoolhouse Rd. Somerset. NJ 08873 Re:
K973886 Oticon DigiSound Compact Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD NOV - 4 1997
Dear Mr. Brunved:
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, 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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.
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,
William Yu, Ph.D.
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
1
Page / of /
510(k) Number (if known): _
Device Name: DigiSound Compact
Indications For Use:
A. General Indications:
The indication for use of the air conduction hearing aids in this the indication for abily sound for individuals with impaired Submission 13 co capices 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.)
-
To amplify and deliver sound to the ear via air conduction
(PLEASE DO HOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ylavid le. de form
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)