(71 days)
General Indications: A. The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight, X 2. Mild, X 3. Moderate, X 4. Severe, 5. Profound. Configuration: X 1. High Frequency - Precipitously Sloping, X 2. Gradually Sloping, X 3. Reverse Slope, X 4. Flat, 5. Other. Other: X 1. Low tolerance To Loudness, 2., 3. B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - l. 2. - 3.
Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
The provided text does not contain information about acceptance criteria or a study proving the device meets these criteria in the typical format of a medical device performance study (e.g., diagnostic accuracy, sensitivity, specificity).
Instead, the documents are a 510(k) Premarket Notification Summary for a hearing aid, the Phonak Novo Forte E3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through a clinical study.
Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and study details:
- Device Description and Intended Use: The documents clearly describe the Phonak Novo Forte E3 as a "Programmable behind-the-ear hearing instrument" intended "To amplify and transmit sound to the ear."
- Technical Characteristics: It states that "Technical specifications comply with ANSI S3.22 - 1987." This is the closest thing to a performance standard or criterion mentioned, but it's a general compliance statement rather than specific device performance metrics.
- Substantial Equivalence: The FDA letter explicitly states, "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This is the core of a 510(k) submission.
- Indications for Use: Page 4 details the specific types and severities of hearing loss for which the device is indicated (Slight, Mild, Moderate, Severe; High Frequency, Gradually Sloping, Reverse Slope, Flat; Low tolerance to Loudness).
Answer based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant industry standards for hearing aids | "Technical specifications comply with ANSI S3.22 - 1987" |
| Ability to amplify and transmit sound | "To amplify and transmit sound to the ear" |
| Substantial equivalence to a legally marketed predicate device | Device determined to be substantially equivalent by the FDA |
Explanation: The document does not specify quantitative performance acceptance criteria (e.g., a required signal-to-noise ratio, hearing gain at specific frequencies, or distortion levels) or present performance data from a specific study against such criteria. The primary "acceptance" was the FDA's determination of substantial equivalence to a predicate device and compliance with ANSI S3.22 - 1987.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. The 510(k) summary does not describe a clinical performance study with a test set of patients or data.
- Data Provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hearing aid; it does not involve algorithms for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No ground truth is established as no clinical performance study is described. The "ground truth" for the 510(k) application is the established safety and effectiveness of the predicate device to which the Novo Forte E3 is compared for substantial equivalence.
8. The sample size for the training set:
- Not applicable/Not provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is mentioned.
{0}------------------------------------------------
K4732006
16
AUG 1 5 1997
Summary of Safety and Effectiveness Information
| Name of Device: | Phonak Novo Forte E3 |
|---|---|
| Type of Device: | Programmable behind-the-ear hearinginstrument. Substantially equivalent to otherprogrammable behind-the-ear hearinginstruments |
| Intended Use: | To amplify and transmit sound to the ear |
| Features: | Two programmable memories, 3 choices ofsignal processing, optional remote control |
| Assembly: | Assembled from components available tohearing instruments manufacturer. Deliveredcompletely assembled to the hearing aiddispenser |
| Technical Characteristics: | Technical specifications comply with ANSIS3.22 - 1987 |
| Audiometric Fit: | Frequency response, gain, and output are fittedto the individual audiogram |
| Controls: | Operated with remote control |
| Power Source: | Standard hearing instrument battery, size 675 |
A user's manual and other information is supplied with each hearing instrument.
{1}------------------------------------------------
Summary of Safety and Effectiveness Information
| Name of Device: | Phonak Novo Forte E3 |
|---|---|
| Type of Device: | Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments |
| Intended Use: | To amplify and transmit sound to the ear |
| Features: | Two programmable memories, 3 choices of signal processing, optional remote control |
| Assembly: | Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser |
| Technical Characteristics: | Technical specifications comply with ANSI S3.22 - 1987 |
| Audiometric Fit: | Frequency response, gain, and output are fitted to the individual audiogram |
| Controls: | Operated with remote control |
| Power Source: | Standard hearing instrument battery, size 675 |
A user's manual and other information is supplied with each hearing instrument.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 1997
Laura M. Voll, M.S. Regulatory Affairs Coordinator Phonak, Inc. 850 E. Diehl Rd. Naperville, IL 60566
Re: K972106
Phonak Novo Forte E3 Hearing Aid Dated: May 30, 1997 Received: June 5, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77ESD
Dear Ms. Voll:
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 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 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 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 hoen decmed 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 electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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Page 2
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,
hollian Yin
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
{4}------------------------------------------------
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Novo Forte E3 Device Name:
Indications For Use:
General Indications: A.
The indication for use of the air conduction hcaring aids in this submission is to amplify sound far 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 | X 1. High Frequency- Precipitously Sloping | X 1. Low toleranceTo Loudness |
| X 2. Mild | X 2. Gradually Sloping | _ 2. |
| X 3. Moderate | X 3. Reverse Slope | _ 3. |
| X 4. Severe | X 4. Flat | |
| _ 5. Profound | _ 5. Other |
B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
- l. 2.
-
(PLEASE DG NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seagram
2
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
§ 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.