MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER

K973665 · Magnatone Hearing Aid Corp. · ESD · Nov 4, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973665
• Device Name: MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNER
• Applicant: Magnatone Hearing Aid Corp.
• Product Code: ESD · Ear, Nose, Throat
• Decision Date: Nov 4, 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: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low Tolerance To Loudness.

Device Story

Magnatone air conduction hearing aids (Models DB, DB2000, PH, ST, CI) amplify sound for individuals with impaired hearing. Devices are worn by patients to assist with various hearing loss configurations; severity ranges from slight to severe. Operation involves capturing ambient sound, processing/amplifying signal, and delivering output to user's ear. Devices are intended for use by individuals with hearing impairment. Healthcare providers (audiologists/hearing aid specialists) fit and adjust devices based on patient audiometric data. Output amplification helps improve auditory perception. Potential benefits include improved ability to hear and communicate in daily environments. Electromagnetic interference from digital cellular phones is noted as a potential risk, which may cause buzzing or temporary ineffectiveness.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air conduction hearing aids; form factors include various models (DB, DB2000, PH, ST, CI). Energy source is battery-powered (including rechargeable options).

Indications for Use

Indicated for individuals with slight to severe hearing loss, including high frequency precipitously sloping, gradually sloping, reverse slope, or flat configurations, and those with low tolerance to loudness.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 1997

Don E. Campbell Magnatone Hearing Aid Corporation 170 N. Cypress Way P.O. Box 180964 Casselberry, FL 32718

Re:

K973665 Hearing Aid Models DB, DB2000, PH, ST and CI Dated: September 23, 1997 Received: September 25, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Campbell:

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 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 clectromagnetic 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 Yin, 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 of ___________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | |
|---------------------------|----------------------|
| Device Name: | MAGNATONE MODEL "CI" |
| Indications For Use: | |

Tradenames:
C.I.C.
S.P.I.
One TouchA. General Indications:

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals In this submission is of the devices are indicated for with imparted hearing. Into dollowing category(ies).

| Severity: | Configuration: | Other |
|---------------|---------------------------------------------|------------------------------|
| X 1. Slight | X 1. High Frequency - Precipitously Sloping | 1. Low Tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| _ 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.)

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2.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K973665 |
| Restricted device (per 21 CFR 801.420 &21 CFR 801.421) | |

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| 510(k) Number (if known): | |
|---------------------------|----------------------|
| Device Name: | MAGNATONE MODEL "DB" |
| Indications For Use: | |

| Tradename |
|------------------|
| Designer Battery |

A. General Indications:

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals In this submitbion is . The devices are indicated for with impaired hearing. In the following category(ies).

| Severity: | Configuration: | Other |
|---------------|---------------------------------------------|------------------------------|
| X 1. Slight | X 1. High Frequency - Precipitously Sloping | 1. Low Tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| 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.)

2.

1.

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| Concurrence of | CDRH, Office of Device Evaluation (ODE) |
|----------------|---------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | 1973665 |

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

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Page of ______________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | |
|---------------------------|--------------------------|
| Device Name: | MAGNATONE MODEL "DB2000" |
| Indications For Use: | |

| Tradename | Designer Battery |
|-----------|------------------|
|-----------|------------------|

A. General Indications:

The indication for use of the air conduction hearing aids
. The are the institution amplify sound for individuals The indication for use of the aif conunction individuals
in this submission is to amplify sound for individuals in this submission 1s co amplify somic rosindicated for with impaired hearing. The devices are marked on

| Severity: | |
|---------------------------------------------|--|
| X 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 | |
| 1. Low Tolerance To Loudness | |
| 2. | |

B. Specific Indications (Only if appropriate.) : ecitic Indications (only it appears as improved speech
(Most psychoacoustic indications such as improved by (Most psychoacoustic Indications Such as Improvention of the supported by clinical data.)

1 . 2.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| | |
| | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| | |
| 510(k) Number | K973665 |
| Restricted device (per 21 CFR 801.420 & 801.421) | |

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Page of of ___________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | |
|---------------------------|----------------------|
| Tradename | Liberty Rechargeable |
| Device Name: | MAGNATONE MODEL "LB" |

Indications For Use:A. General Indications:

The indication for use of the air conduction hearing aids
to the same in the simplies sound for individuals The indication for use of the differenund for individuals
in this submission is to amplify sound for indicated for in this submission is to ampilly somia ror indicated for with impaired hearing. The devices are

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

B. Specific Indications (Only if appropriate.) : ecitic Indications (olify it approved speech
(Most psychoacoustic indications such as improved by (Most psychoacouscic Indications background noise, must be supported by intelligibility in background noise, must be supported by clinical data.)

1 . 2.

i

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

| Concurrence of | CDRH, Office of Device Evaluation (ODE) |
|----------------|--------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K973665 |

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

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of Paqe

| 510(k) Number (if known): | |
|---------------------------|----------------------|
| Tradename | Pearl |
| Device Name: | MAGNATONE MODEL "PH" |

Indications For Use:A. General Indications:

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 with imparred nearing.
individuals with losses in the following category(ies).

| Severity: | Configuration: | Other |
|---------------|------------------------------------------------|---------------------------------|
| X 1. Slight | X 1. High Frequency<br>- Precipitously Sloping | 1. Low Tolerance<br>To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | |
| 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.)

1. 2.

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| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973665 |

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

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of Page

| 510(k) Number (if known): | |
|---------------------------|----------------------|
| Device Name: | MAGNATONE MODEL "ST" |
| Tradename | Sterling |

Indications For Use:A. General Indications:

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: | Configuration: | Other |
|---------------|---------------------------------------------|------------------------------|
| ❌ 1. Slight | ❌ 1. High Frequency - Precipitously Sloping | 1. Low Tolerance To Loudness |
| ❌ 2. Mild | ❌ 2. Gradually Sloping | 2. |
| ❌ 3. Moderate | ❌ 3. Reverse Slope | |
| ❌ 4. Severe | ❌ 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.)

1.

2.

(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, and Radiological Devices | |

| 510(k) Number | K973665 |
|---------------|---------|
|---------------|---------|

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