TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC

K974751 · General Hearing Instruments, Inc. · ESD · Mar 6, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974751
• Device Name: TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
• Applicant: General Hearing Instruments, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Mar 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

A hearing Aid and/or Tinnitus Masker/Habituator

Device Story

Tranquil TRI-OE, TRI-COE, and TRI-CIC are hearing aids and tinnitus masker/habituators. Devices utilize Class A or Class D noise generators and DSD K-amp or Intrigue programmable circuitry. Frequency response is customized based on individual audiograms. Devices are operated by patients to manage tinnitus symptoms and/or hearing loss. Output is sound generation to mask or habituate tinnitus, with volume controlled mechanically or electronically. Powered by standard size 312 or 10A batteries. Intended for use in daily life activities to assist patients struggling with tinnitus-related anxiety or functional impairment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Class A or Class D noise generator; DSD K-amp or Intrigue programmable circuitry; frequency response adjusted via audiogram; mechanical or electronic volume control; powered by size 312 or 10A batteries; complies with S3.2-1987 ANSI standards.

Indications for Use

Indicated for patients with no hearing loss or mild to severe high-frequency hearing loss who exhibit intolerance to tinnitus, characterized by an inability to cope with head noises, anxiety, depression, or inability to function in daily life activities.

Regulatory Classification

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.

Submission Summary (Full Text)

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q74751

## A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE: Tranquil™ TRI-OE MAR - 6 1998 TYPE OF DEVICE: I-T-E

INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,

DSD K-amp programmable or Intrigue Programmable ASSEMBLY: Assembled from standard components that are widely used by other hearing aid manufactures

"Technical specifications TECHNICAL CHARACTERISTICS: comply with S3 2-1987 ANSI Standards"

FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic Standard Size 312 battery POWER:

> A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.

> > ATTACHMENT I

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## A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE: Tranquel TRI-COE

TYPE OF DEVICE: I-T-C

INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,

DSD K-amp programmable or Intrigue Programmable ASSEMBLY: Assembled from standard components that are widely

used by other hearing aid manufactures TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3 2-1987 ANSI Standards"

FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic Standard Size 10A battery POWER:

> A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.

## ATTACHMENT I

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A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

NAME OF DEVICE: Tranquel TRI-CIC

TYPE OF DEVICE: C-I-C

INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,

DSD K-amp programmable or Intrigue Programmable

ASSEMBLY: Assembled from standard components that are widely used by other hearing aid manufactures

TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3 2-1987 ANSI Standards"

FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic

Standard Size 10A battery POWER:

> A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.

## ATTACHMENT I

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 1998

Roger P. Juneau President General Hearing Instruments, Inc. P.O. Box 23748 New Orleans, LA 70183-0748

Re: K974751

Tranquil TRI-OB, TRI-COE & TRI-CIC Tinnitus Maskers /Hearing Aids Dated: December 17, 1997 Received: December 19, 1997 Regulatory class: III 21 CFR 874.3400/21 CFR 874.3300 Procode: 77 KLW/77 ESD

Dear Mr. Juneau:

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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

William Yi

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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3 Page 1 of

510(k) Number (if known): K97475

Tranqui1 tm TRI-OE Device Name:

Indications For Use:

No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low nearing foss where the patient the patient's response. to tinnitus is characterized by intolerence. to cinnitus is charactlity to cope with head noises , Specifically the Thability of offer to function in daily life activities . When cosmetics are not an issue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT,

Radiological Devices
510(k) Number K974757

Prescription Use Y (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

**Restricted Device**
Per 874.420 and 421

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Page_2_ _of_3

510(k) Number (if known): 1497475 L

Device Name: Tranqui 1 tm TRI-COE

Indications For Use:

No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low nearing foss when the patient's response. to tinnitus is characterized by intolerence. co cifically the inability to cope with head noises . Specifically the rhability to objection news.
anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sion-Off) of Reproductive. Abdominal. ENT.

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

icted De if 874.420 and 4

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510(k) Number (if known): प्रिं९७४७ ५८

Device Name: Iranqui] tm IRI-CIC

Indications For Use:

No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low nearing ross there the patient's response. to tinnitus is characterized by intolerence. to cifically the inability to cope with head noises, Specifically chevro or the inability to function in daily life activities. When cosmetics are a major issue.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division. Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number K974727

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use ..........

(Optional Format 1-2-96)

Restricted Device Per 874.420 and 421