K Number

Device Name

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

Manufacturer

MAGNATONE HEARING AID CORP.

Date Cleared

1997-11-04

(40 days)

Product Code

ESD

Regulation Number

874.3300

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 Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of these technologies.

Therapeutic

Yes
The device is a hearing aid, which is used to amplify sound for individuals with impaired hearing, thereby alleviating a medical condition.

Diagnostic

No
Explanation: The device is an air conduction hearing aid, indicated to amplify sound for individuals with impaired hearing. This is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

The summary describes air conduction hearing aids, which are hardware devices that amplify sound. There is no mention of software being the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "amplify sound for individuals with impaired hearing." This describes a device that interacts with the patient's body (the ear) to improve a physical function (hearing).
Anatomical Site: The anatomical site is the "Ear." This further confirms it's a device used on the body.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is clearly designed to be used on the body to assist with hearing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 with impaired hearing individuals with losses in the following category(ies).

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:

Low Tolerance To Loudness
Not Found

Product codes (comma separated list FDA assigned to the subject device)

77 ESD

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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 (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 (301) 443-6597 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

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.)

(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)

of of Page Page

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.)

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

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)

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.

(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 & 801.421)

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.

(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)

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

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.)

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

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)

of Page

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

Indications For Use:A. General Indications:

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.)

(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)