LORI/LORI, LORI-S (LORI STOCK AID)

K973376 · Lori Medical Laboratories, Inc. · ESD · Oct 14, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973376
• Device Name: LORI/LORI, LORI-S (LORI STOCK AID)
• Applicant: Lori Medical Laboratories, Inc.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Oct 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies): Severity: Mild, Moderate; Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat.

Device Story

LORI/LORI-S are air conduction hearing aids designed to amplify sound for patients with mild to moderate hearing loss. The device functions by capturing ambient sound, processing it to provide amplification, and delivering the output to the user's ear canal. It is intended for use by individuals with specific hearing loss configurations (high frequency sloping, gradually sloping, or flat). The device is operated by the patient to assist in daily auditory perception. It serves as a traditional hearing aid to improve speech and sound clarity for the wearer.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device classification and intended use.

Technological Characteristics

Air conduction hearing aid; 21 CFR 874.3300; Procode 77 ESD. Device is a restricted device per 21 CFR 801.420 and 801.421.

Indications for Use

Indicated for individuals with mild to moderate hearing loss, specifically those with high frequency precipitously sloping, gradually sloping, or flat hearing loss configurations.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 4 1997

Re: K973376

LORI/LORI, LORI-S (LORI STOCK AID) Air Conduction Hearing Aid Dated: September 8, 1997 Received: September 8, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD

Gary Maas President, Lori Medical Laboratories 696 Mendelssohn Avenue, North Golden Valley, MN 55427

Dear Mr. Maas:

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 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 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 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 Yip, Ph.D.

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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Page / of /

| 510(k Number (if known): | K973376 |
|--------------------------|---------|
| Device Name: | LORD-S |

Indicitions For Use:

A. Gereral:

The indication for use of the air conduction hearing aids in this submission is to anglify sound for individuals with impaired The devices are indicated for individuals with losses in hearing. the following category(fes), (Check appropriate space(s));

| Severity: | |
|---------------------------------------------|------------------------------|
| 1. light | |
| X 2. Mild | |
| X 3. Moderate | |
| 4. Severe | |
| 5. Profound | |
| Configuration: | Other |
| X 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness |
| X 2. Gradually Sloping | 2. __________ |
| 3. Reverse Slope | 3. __________ |
| X 4. Flat | |
| 5. Other __________ | |

B Specific (List Claims): (Most psychofacoustic claims, including those pertaining to the widerstanding of speech in notse, must be supported by clinical dica. )

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Concurrence of CDRH, Difice of Device Evaluation (ODE)

Restricted device (per 21 CPR 801.420 & 21 CPR 801.421)

David A. Bergman

(Division Sign-Off) Division of Renductive. Abdominal, ENT, and Radiologic 510(k) Number