(24 days)
Not Found
No
The description details a digitally programmable hearing aid with various adjustable parameters and features like compression and voice activity detection, but it does not mention any AI or ML algorithms for processing or adapting to sound environments. The programming is done by a dispenser using specific software and hardware based on the individual's audiogram.
Yes
This device is intended to help compensate for impaired hearing, which is a medical condition, making it a therapeutic device.
No
Explanation: The device description states it is a "wearable sound-amplifying device that is intended to help compensate for impaired hearing." Its function is to amplify sound, not to diagnose hearing impairment.
No
The device description explicitly details hardware components like "Behind the Ear and Custom Hearing Instruments," "digital signal processor," "Twin Microphone System," and user adjustable controls like switches. It also mentions assembly from "standard components." This indicates a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is a wearable sound-amplifying device intended to compensate for impaired hearing. It works by electronically amplifying sounds and transmitting them to the ear. This is a direct interaction with the user's auditory system, not an analysis of a biological specimen.
- Intended Use: The intended use clearly states it's for compensating for impaired hearing, which is a functional issue, not a diagnostic test performed on a sample.
The device described is a hearing aid, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
A wearable sound-amplifying device that is intended to help compensate for impaired hearing. Sounds are electronically amplified and transmitted to the ear.
Product codes (comma separated list FDA assigned to the subject device)
77 ESD
Device Description
PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments. The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses. It features digital control of a highly flexible digital signal processor
Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response, depending on the model configuration. These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, Second Program.
Assembled from standard components that are widely utilized by other hearing aid manufacturers.
Technical specifications comply with s3.22-1987 ANSI Specifications.
The frequency response of the product is dictated by the individual Audiogram from each client and the settings of the programmable controls.
User adjustable controls may be found on the Behind-the-Ear model which include a Microphone-Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories. Depending on the specific configuration of the instrument as ordered by the hearing instrument professional, some of these user controls may not be present. With the custom products, PRISMA comes standard with no user adjustable controls unless specifically requested by the hearing instrument professional, in which case a push button switch and/or directional microphone is available.
Standard Hearing Aid Batteries: 5A,10A, 13, 312 and 675.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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.
Not Found
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.
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
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Siemens PRISMA Behind the Ear and Custom Hearing Instruments |
|---|---|
| SEP - 5 1997 | |
| Type of Device: | Behind the Ear and Custom Hearing aid substantially equivalent to other Behind the Ear (BTE) and Custom hearing aids (In The Ear, In The Canal, Half Shell, Mini-Canal, Completely In the Canal) on the market. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Features: | PRISMA Behind the Ear and Custom Hearing Instruments are digitally programmable instruments. The dispenser programs the instrument using Siemens PC CONNEXX software with HiPro ™ hardware (K942749), Siemens Personal Programmer 2000, or UNITY with HiPro hardware This device is intended to compensate for a wide range of moderate to severe hearing losses including flat, ski-slope and reverse slope losses. It features digital control of a highly flexible digital signal processor |
| Up to 32 digitally adjustable parameters and two listening situations (memories) are accessible to shape and modify the instrument's response, depending on the model configuration. These include: Channel Delineation, Curvilinear Compression, Linear Compression, Syllabic Compression, Dual Compression, Voice Activity Detection System, Channel Gain, Cross Channel Shaping, Interchannel coupling, Twin Microphone System/Direction Mic, Low level Squelch, | |
| Second Program. | |
| Assembly: | Assembled from standard components that are widely utilized by other hearing aid manufacturers. |
| Technical Characteristics: | Technical specifications comply with s3.22-1987 ANSI Specifications |
| Fit: | The frequency response of the product is dictated by the individual Audiogram from each client and the settings of the programmable controls. |
| Controls: | User adjustable controls may be found on the Behind-the-Ear model which include a Microphone- Telecoil-Off (M-T-O) switch, and a momentary push-button switch to change between the two stored memories. Depending on the specific configuration of the instrument as ordered by the hearing instrument professional, some of these user controls may not be present. With the custom products, PRISMA comes standard with no user adjustable controls unless specifically requested by the hearing instrument professional, in which case a push button switch and/or directional microphone is available. |
| Power: | Standard Hearing Aid Batteries: 5A,10A, 13, 312 and 675 |
A User's manual and General Information for Hearing Aid Users Guide is supplied with each hearing aid.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle or other bird, with its wings outstretched. The image is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Robert H. Bea Director of Quality Assurance & Regulatory Affairs Siemens Hearing Instrument, Inc. 10 Constitution Avenue P.O. Box 1397 Piscataway, New Jersey 08855-1397
Re:
K972998 PRISMA Digital Hearing Aid Dated: August 8, 1997 Received: August 12, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Bea:
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 Aproval), 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 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 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 aid 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 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,
William Yhi
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
DEVICE INDICATION FOR USE
Device Name:
Classification Name: Common/Usual Name:
Air Conduction Hearing Aid Behind the Ear, In the Ear, Half Shell, In the Canal, Mini-Canal and Completely in the Canal Hearing Aid.
Establishment Registration Number: 2217809 Registration No .:
A wearable sound-amplifying device that is intended to help cmpensate for Indication for Use: impaired hearing. Sounds are electronically amplified and transmitted to the ear.
I certify that, in my capacity as Director of Quality Assurance & Regulatory Affairs of Siemens Hearing Insatruments, Inc., I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
Signature
Robert H. Bea, Director of Quality Assurance & Regulatory Affairs
August 18, 1997
Date
Thind Ch. Seymour
(Division Sign-Off)
Restricted Device Per 874.420 and 421
Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number
-
- Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter.)