(57 days)
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: Slight, Mild, Moderate, Severe
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance To Loudness
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments.
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 312
The provided documents describe a 510(k) premarket notification for the Phonak Epica E 2 hearing instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove novel acceptance criteria.
Therefore, the following information is either not applicable or not explicitly detailed in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance Study:
The document states that the "Technical specifications comply with ANSI S3.22 - 1987." This implies that compliance with this industry standard serves as the acceptance criterion for technical performance. However, specific numerical acceptance criteria (e.g., gain, output, frequency response ranges) and the corresponding reported device performance values against these criteria are not provided within the given text.
A standalone performance study, in the sense of a clinical trial to establish new performance metrics, is not detailed as the submission's goal is substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/not specified. The 510(k) summary does not mention a specific test set or data provenance for a clinical study comparing the device against acceptance criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable/not specified. No information regarding experts establishing ground truth is provided, as clinical efficacy data is not the primary focus of this 510(k) submission.
4. Adjudication Method:
Not applicable/not specified. No adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are typically used in medical imaging to assess the impact of AI on human reader performance. This device is a hearing aid, and this type of study is not relevant to its regulatory pathway.
7. Type of Ground Truth Used:
Not applicable. Since the submission focuses on substantial equivalence to a predicate device and compliance with a technical standard (ANSI S3.22-1987), there's no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical efficacy.
8. Sample Size for the Training Set:
Not applicable/not specified. There is no information about a training set or specific machine learning algorithms for this device.
9. How the Ground Truth for the Training Set was Established:
Not applicable/not specified. As with point 8, no training set or its ground truth establishment is discussed.
Summary based on the provided text:
The information primarily indicates that the device's technical characteristics comply with ANSI S3.22-1987, which serves as a key acceptance criterion for its fundamental performance. The 510(k) process is about demonstrating substantial equivalence, not conducting de novo clinical trials to prove new performance criteria.
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Summary of Safety and Effectiveness Information
AUG -- 1 1997
| Name of Device: | Phonak Epica E 2 |
|---|---|
| Type of Device: | Programmable in-the-canal hearinginstrument. Substantially equivalent toother programmable in-the-canal hearinginstruments |
| Intended Use: | To amplify and transmit sound to the ear |
| Features: | Two programmable memories, 3 choicesof signal processing, optional remotecontrol |
| Assembly: | Assembled from components available tohearing instruments manufacturer.Delivered completely assembled to thehearing aid dispenser |
| Technical Characteristics: | Technical specifications comply withANSI S3.22 - 1987 |
| Audiometric Fit: | Frequency response, gain, and output arefitted to the individual audiogram |
| Controls: | Operated with remote control |
| Power Source: | Standard hearing instrument battery, size312 |
A user's manual and other information is supplied with each hearing instrument.
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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. In the center of the circle is an image of a stylized bird with three overlapping wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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AUG - I 1997
Laura M. Voll, M.S. Regulatory Affairs Coordinator Phonak, Inc. 850 E. Diehl Rd. P.O. Box 3017 Naperville, IL 60566
Re: K972105
Phonak "Epica E 2" Dated: May 30, 1997 Received: June 5, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Voll:
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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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure 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 celiular 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 incliective 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitto 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 (30:3 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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
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510(k) Number (if known):
Epica E2 Device Name:
Indications For Use:
- 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: | Configuration: | Other |
|---|---|---|
| X 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 |
Specific Indications (only if appropriate.): B. (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Restricted device (per 21 CFR 801.420 & 21 CFR 801.421) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal ENT,and Radiological Devices | |
| 510(k) Number | K972105 |
§ 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.