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

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

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for several hearing aid models (DB, DB2000, PH, ST, CI) manufactured by Magnatone Hearing Aid Corporation. It primarily states that the devices are substantially equivalent to legally marketed predicate devices and can proceed to market. It also includes "Indications For Use" forms for each model.

Based on the provided text, the acceptance criteria and study information are quite limited because this is a regulatory clearance document, not a detailed scientific study publication. The 510(k) pathway demonstrates substantial equivalence rather than requiring a full clinical trial meeting specific performance criteria in the way a PMA (Premarket Approval) would.

Here's an analysis based on the information provided, with an understanding of the limitations inherent in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The "performance" described relates to the indications for use.

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance
Substantial Equivalence to legally marketed predicate devices.	The FDA determined the devices are "substantially equivalent" to devices marketed prior to May 28, 1976, or to lawfully reclassified devices (Page 1).
Device must amplify sound for individuals with impaired hearing.	"The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing." (Pages 3-7 for all models).
Device must be indicated for specific severities of hearing loss (Slight, Mild, Moderate, Severe, Profound).	All models (CI, DB, DB2000, LB, PH, ST) are indicated for "Slight", "Mild", "Moderate", and "Severe" hearing loss. The "Profound" category is generally unchecked, except for DB and DB2000 where it is also indicated "X" (Pages 3-7).
Device must be indicated for specific configurations of hearing loss (High Frequency, Gradually Sloping, etc.).	All models (CI, DB, DB2000, LB, PH, ST) are indicated for "High Frequency - Precipitously Sloping", "Gradually Sloping", "Reverse Slope", and "Flat" configurations (Pages 3-7).
Device may be indicated for "Low Tolerance To Loudness."	All models (CI, DB, DB2000, LB, PH, ST) include "Low Tolerance To Loudness" as an "Other" indication option (Pages 3-7).
Specific psychoacoustic indications (e.g., improved speech intelligibility in background noise) require clinical data support.	No specific psychoacoustic indications are checked or discussed. The forms explicitly state: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)" This implies such claims were not made for these devices in this submission, or if they were, they needed separate clinical data, which is not included here (Pages 3-7).

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) submission, the primary evidence is typically technical specifications and comparison to a predicate device, not a new clinical study with a "test set" in the traditional sense of a clinical trial. The "clinical data" mentioned for specific psychoacoustic indications (if made) would typically be provided elsewhere, if at all.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The concept of "ground truth" established by experts for a test set is usually associated with clinical studies involving diagnostic or prognostic devices, where human expert labels are compared to device outputs. For hearing aids seeking 510(k) clearance, the "ground truth" for their substantial equivalence is the predicate device's established safety and effectiveness.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant when multiple experts are interpreting data, and consensus is needed to establish ground truth for a clinical study. This document does not describe such a study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned or implied in this document. These types of studies are used to assess the performance of a device with human readers, often comparing human performance with and without AI assistance. This document is a regulatory clearance for a physical medical device (hearing aids), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a hearing aid, which is a physical device used by a human, not a standalone algorithm. Its performance is directly tied to a human wearer.

7. The Type of Ground Truth Used

For the purpose of this 510(k) clearance, the "ground truth" essentially refers to:

Predicate Device Performance: The safety and effectiveness of the legally marketed predicate device(s) to which the Magnatone hearing aids are compared. This is the cornerstone of substantial equivalence.
Established Medical Understanding: The classifications of hearing loss severity and configuration (Slight, Mild, High Frequency, Flat, etc.) are based on established audiological standards and medical understanding.

There is no mention of pathology, expert consensus (beyond the regulatory review process), or outcomes data being used to establish ground truth for a novel study of these specific devices within this document.

8. The Sample Size for the Training Set

This information is not applicable/not provided. These are physical hearing aid devices, not AI/machine learning algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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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 (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

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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.)

(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)

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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)

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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.

(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)

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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.

(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- Precipitously Sloping	1. Low ToleranceTo 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)

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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)

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.