DANAVOX MODELS 163/162 BTE by GN DANAVOX, INC.

The provided text is a 510(k) Pre-market Notification for the Danavox 163 / 162 BTE hearing aids. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through a clinical trial with specific performance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission would.

Here's why and what information can be gleaned:

Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that the new device has the same intended use and similar technological characteristics, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.
Performance Specifications: The document states that "The intended use, performance specifications, functions and operations of the Danavox 163 / 162 BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura." This implies the Danavox Aura's performance specifications serve as the de facto acceptance criteria. However, those specific criteria are not detailed in this document.

Information NOT present in the document:

A table of acceptance criteria and reported device performance (for the 163/162 BTE specifically).
Sample size for a test set or data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance (as this is a hardware device, not an AI/algorithm).
Type of ground truth used (as there's no clinical study described).
Sample size for a training set (as there's no machine learning/AI component).
How ground truth for a training set was established.

Information that can be inferred or extracted (but not in the format requested):

While there are no explicit acceptance criteria or a study detailed in the document, the basis for market clearance is "substantial equivalence." The predicate device's performance specifications are implicitly the target.

Intended Use/Performance Description (from the document):

Feature/Specification	Danavox 163 / 162 BTE	Predicate Device (Danavox Aura)	Equivalence Claim
Intended Use	Compensates for hearing losses from mild to severe by amplifying sound pressure waves and transmitting the signal to the external ear through air.	Same	Essentially identical
Device Type	Air-conduction behind-the-ear hearing instrument with body-worn processor.	Same	Same
Power Source	Model 163: type 13 battery. Model 162: type 312 battery.	Not specified, but standard hearing aid batteries expected.	Standard hearing aid batteries
Manufacturing	Manufactured and delivered completely assembled using widely used materials and techniques.	Same	Widely used techniques
Fitting Parameters	Ability to program digitally.	Same	Same
Sound Processing	Ability to change characteristics and adjust volume.	Same	Same
Memory Programs	Retains up to three programs.	Retains four programs.	Difference noted, but implies it does not raise new questions of safety/effectiveness as 3 programs is still a functional equivalent for basic use.

Summary of "Acceptance Criteria" and "Study" based on a 510(k) Submission:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to the predicate device, the Danavox Aura (K905692). The "study" proving this is effectively the comparison provided in the summary of safety and effectiveness, which highlights similarities in intended use, technological characteristics, and performance.

Table of Acceptance Criteria and Reported Device Performance: Such a table is not provided. The document states the performance specifications, functions, and operations are "essentially identical" to the predicate device. The only noted difference is memory capacity (3 programs vs. 4 for the predicate), which was deemed acceptable.
Sample Size and Data Provenance: Not applicable, as this is a comparison to a predicate device, not a new clinical study.
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable (not an AI device).
Standalone Performance: The "standalone" performance is understood to be the inherent functionality of the hearing aid, which is asserted to be "essentially identical" to the predicate device. No new standalone performance study is detailed.
Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate device.
Sample Size for Training Set: Not applicable (not an AI device).
How Ground Truth for Training Set Was Established: Not applicable (not an AI device).

Summary

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Image /page/0/Picture/0 description: The image shows the word "DANAVOX" in large, bold, black letters. Below the word, in smaller letters, is the phrase "Partners in Hearing Care". The text is centered and the font is a serif typeface.

JUN | 7 1997

K971032

Danavox 163 / 162 BTE

SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence for the Danavox 163 / 162 BTE to the predicate device, the Danavox Aura 510(k) No. K905692 is based on the following:

This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to . amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.
The device is powered by a standard hearing aid battery (Model 163 type 13 , Model 162 -● type 312) .
The device is manufactured and delivered completely assembled to the hearing aid dispenser . using materials and techniques widely used by other manufacturers of hearing devices.
The intended use, performance specifications, functions and operations of the Danavox 163 / 162 ● BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura.
The ability to program digitally the fitting parameters of the hearing device is the same as in the ● Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume.
The Danavox 163 / 162 BTE has the ability to retain up to three programs in memory, whereas ● the predicate device can retain four programs in memory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 17 1997

Mr. Wayne Morris Director of Operations GN Danavox, Inc. 5600 Rowland Road, #250 Minnetonka, MN 55343

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K971032

DANAVOX Model 163/162 BTE Hearing Aids Dated: March 20, 1997 Received: March 21, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Morris:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 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), 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 at (301) 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): ____________________________________________________________________________________________________________________________________________________

Danavox Model 163/162 BTE Device Name:_

Indications For Use:

a. General Indications:

The indication for use of the air conduction hearing aius in this The indication for use of the arr condividuals with impaired submission is to amplity sound tor individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices are indicated for indivi hearing. The devices are indicated books. In the space(s)):

Severity:	Configuration:	Other
1. Slight	X 1. High Frequency - Precipitously Sloping	X 1. Low tolerance To Loudness
X 2. Mild	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 psychoacoustic 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)

David A. Segman

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K971032
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Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

Regulation Number and Section

§ 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.