K Number

Device Name

TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05

Manufacturer

NATIONAL HEARING AID DIST., INC.

Date Cleared

1997-06-20

(74 days)

Product Code

ESD

Regulation Number

874.3300

Intended Use

The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies).

Device Description

Tondi BTE Hearing Aid, Models U-2011, U-214, U-03, KA-02, KA-03, KA-UBA, KA-01, KA-04, KA-04A, KA-05

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 does not mention AI, ML, or any related terms or concepts like training/test sets, performance metrics typically associated with AI/ML models, or image processing (which can sometimes be AI-driven). The description is limited to the basic function and models of a hearing aid.

Therapeutic

No
A hearing aid amplifies sound to compensate for impaired hearing; it does not treat or cure the hearing impairment, so it is not considered a therapeutic device.

Diagnostic

No
Explanation: The device is described as a hearing aid intended to amplify sound for individuals with impaired hearing. Its purpose is to assist with hearing, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists models of "BTE Hearing Aid," which are Behind-the-Ear hardware devices. The intended use also describes amplifying sound, which is a function of hardware components in a hearing aid.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states this is an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." This is a device that interacts with the external environment (sound waves) and the user's ear to improve hearing, not to analyze biological samples.

The information provided strongly indicates this is a Class I or Class II medical device regulated for hearing assistance, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Tondi BTE Hearing Aid, Models U-2011, U-214

Severity:		Configuration:		Other:
1. Slight		1. High frequency Precipitously sloping		1. Low tolerance to loudness
2. Mild	✓	2. Gradually sloping	✓	2. High Tolerance
3. Moderate	✓	3. Reverse Slope		3. Normal Tolerance	✓
4. Severe		4. Flat	✓
5. Profound		5. Other

Tondi BTE Hearing Aid, Model U-03

Severity:	Configuration:	Other:
☐ 1. Slight	☑ 1. High frequency Precipitously sloping	☐ 1. Low tolerance to loudness
☐ 2. Mild	☑ 2. Gradually sloping	☑ 2. High Tolerance
☑ 3. Moderate	☐ 3. Reverse Slop	☐ 3. Normal Tolerance
☑ 4. Severe	☐ 4. Flat
☐ 5. Profound	☐ 5. Other

Tondi BTE Hearing Aid, Model KA-02

The indications for use of this air conduction hearing aid in this sumission is indicated for individuals with imained hearing.... The device(s) is/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. High Tolerance
3. Moderate	3. Reverse Slope	3. Normal Tolerance
4. Severe	4. Flat
5. Profound	5. Other

Tondi. BTE Hearing Aid Models KA-03, KA-UBA

The indications for use of this air conduction hearing aid in this selemission is a more to anplify sound for individuals with impaired hearing. The device(s) is/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. High Tolerance
3. Moderate	3. Reverse Slope	3. Normal Tolerance
4. Severe	4. Flat
5. Profound	5. Other

Tondi BTE Heering Aid, Models KA-01, KA-04, KA-04A

The indications for use of this air conduction hearing aid in this submission is ---------------------------------------------------------------------------------------------- to anplify sound for individuals with impaired hearing. The device(s) is/are would and an 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. High Tolerance	✓
3. Moderate	✓	3. Reverse Slope		3. Normal Tolerance
4. Severe	✓	4. Flat
5. Profound		5. Other

Tondi BTE Hearing Aid, Model KA-05

The indications for use of this air conduction hearing aid in this subimission is to amplify sound for individuals with imparied hearing. The device(s) is/are irticated for individuals with losses in the following catagory(iss).

Severity:	Configuration:	Other:
1. Slight	1. High frequency Precipitously sloping	1. low tolerance to loudness
2. Mild	2. Gradually sloping	2. High Tolerance
3. Moderate	3. Reverse Slop	3. Normal Tolerance
4. Severe	4. Flat
5. Profound	5. Other

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

77 ESD

Device Description

Tondi BTE Hearing Aids

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/0 description: The image shows a partial view of a logo and the word "DEPARTMENT". The logo is on the left side of the image and appears to be a stylized representation of three curved lines. The word "DEPARTMENT" is in all capital letters and is located to the right of the logo. The image is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Paul Menezes ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Engineer National Hearing Aid Distrubutors 301 U.S. Route One Scarborough, ME 04074

Re: K971296..

Tondi BTE Hearing Aids
Dated: April 7, 1997
Received: April 7, 1997
Regulatory class: I
21 CFR 874.3300/Procode: 77 ESD

な Dear Mr. Menezes:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 at (301) 443-6597 or at its Internet address ......... a ----"http://www.fda.gov/cdrh/dsmamain.html":

Sincerely yours,

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

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ K971296

Device Name: Tondi BTE Hearing Aid, Models U-2011, U-214 Indications For Use:

The indications for use of this sir conticlion hearing aid in this submission is to arplify sound for indivisionals with inpaired hearing. The device(s) is/are indicated for individuals with lasses 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. High Tolerance
3. Moderate	✓	3. Reverse Slope		3. Normal Tolerance	✓
4. Severe		4. Flat	✓
5. Profound		5. Other

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

Concurrence of CDRH. Office of Device Evaluation (ODF)

Vernon C. Severson

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

510(k) Number K911296

Hearing aid partis Reseiried dovice (per 21 CFR 801 420 & 21 CFR KU! . 421 Masker portion is Prescription device (per 21 CFR 801.109)

TOTAL F.CIA

Page 2 of E

510(k) Number(if known):

Device Name: Tondi BTE Hearing Aid, Madel U-03 Indications For Use:

The indications for use of this air conduction hearing aid in this submission is :・・ to anolify sound for individe als with impaired hearing. The device(s) is/are 1. 1. 1. 1. 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. High Tolerance
☑ 3. Moderate	☐ 3. Reverse Slop	☐ 3. Normal Tolerance
☑ 4. Severe	☐ 4. Flat
☐ 5. Profound	☐ 5. Other

(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF : TEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K971296

Heuring aid part is Restienced device iper 21 CFR 801.420 & 21 CFR 801.421 Masker portion is Prescription device (per 21 CFF. 801.109)

FETAL F. Ca

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

Device Name: Tondi BTE Hearing Aid, Model KA-02 Indications For Usc:

The indications for use of this air conduction hearing aid in this sumission is indicated for andividuals with imained hearing.... The device(s) is/are ﻟﻤﺼﺎﺩﺭ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ 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. High Tolerance
3. Moderate	3. Reverse Slope	3. Normal Tolerance
4. Severe	4. Flat
5. Profound	5. Other

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

Concurrence of CDRH. Ottice of Device Evaluation (ODF)

Elinli Slegerm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Hewing ald partis Reserience dovice (per 21 CFR 801 420 & 21 CFR 801.421 Masker portion is Frescription device (per 21 CFR 801 420 8
Masker portion is Frescription device (per 21 CFP. 801. 109)

510(k) Number(if known):

Device Name:

Tondi. BTE Hearing Aid Models KA-03, KA-UBA
Indications For Use;

The indications for use of this air conduction hearing aid in this selemission is a more to anplify sound for individuals with impaired hearing. The davice(s) is/are indicated for individuals with losses in the following category(ies).

Severity:
1. Slight
2. Mild
3. Moderate
4. Severe
5. Profound

Configuration:
1. High frequency
Precipitously sloping
2. Gradually sloping
3. Reverse Slope
4. Flat
5. Other

Other:
1. Low tolerance
to loudness.
2. High Tolerance
3. Normal Tolerance

(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF YEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)

David W. Johnson
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _

Heating ald partis Restiered dovice (pcc 21 CFR 801 420 & 21 CFR 801.421 Masker portion is Frescription device (per 21 CFR 801.109)

12425 - 194

Page 5 of 6

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

Device Name: Tondi BTE Heering Aid, Models KA-01, KA-04, KA-04A Indications For Use:

Severity:
1. Slight
2. Mild
3. Moderate	✓
4. Severe	✓
5. Profound

Configuration:
1. High frequency
Precipitously sloping	✓
2. Gradually sloping	✓
3. Reverse Slope
4. Flat
5. Other

Other:
1. Low tolerance to loudness
2. High Tolerance	✓
3. Normal Tolerance

(FLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF YEEDED)

Concurrence of CDRH. Offico of Device Evaluation (ODF)

Elland le. Segerin
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971296

Houring aid part is Resuised dovice (pcr 21 CFR 801.420 & 21 CFR 801.421 Masker portion Is Prescription device (per 21 CFR 801.420 a

Page 6 of 6

510(k) Number(if known): K971296

Device Name: Tondi BTE Hearing Aid, Model KA-05 Indications For Usc:

Severity:	Configuration:	Other:
1. Slight	1. High frequency
Precipitously sloping	1. low tolerance
to loudness
2. Mild	2. Gradually sloping	2. High Tolerance
3. Moderate	3. Reverse Slop	3. Normal Tolerance
4. Severe	4. Flat
5. Profound	5. Other

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF YEEDED)

Concercence of CDRH. Office of Device Evaluation (ODE)

Qhant L. Legan

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _

Heating aid part is Restricted dovice (por 21 CFR 801 420 & 21 CFR 801,421 M89kcr portion is Prescription device (per 21 CFR 801.109)

TOTAL E , 04