Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text does not contain any keywords or descriptions related to AI or ML technology.

Therapeutic

Yes
The device is intended to amplify sound for individuals with impaired hearing, which directly addresses a health condition.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" states the device is "to amplify sound for individuals with impaired hearing." This describes a therapeutic or assistive device, not one used to identify or diagnose a condition.

SaMD (Software as a Medical Device)

No

The summary describes air conduction hearing aids, which are hardware devices that amplify sound. There is no mention of software as 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 physical environment (sound waves) and provides a therapeutic benefit (improved hearing).
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition based on the analysis of biological samples
- Being used in a laboratory setting

IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Hearing aids do not fit this description.

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 individuals with losses in the following category(ies):
- Severity: Slight, Mild, Moderate, Severe, Profound
- Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other
- Other: Low tolerance To Loudness, WITH LOUD INPUT LEVELS POSSIBLE, DISTORTION, High tolerance to Loudness.
Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
- Good for patients with conductive HL.
- Ideal for patients with sensorineural HL.
- Good for those with narrow dynamic range.
- Good for severe - profound HL. whether conductive mixed or SNHL.
- Good for moderate - severe mixed or conductive HL.
- Benefits a mild-moderate sensorineural.
- Good for Sensorin.
- Good for SensoriNeural. hearing Loss.
- SPECIFICALLY FOR those with re.
- Ideal.
- Good for mud-severe Sensorine.
- Appropriate HA for those exposed to ConAnvous Mist as well as Short and Abrupt sudden Noises.
- Miniature Size - Good for non-addicts.
- Good for Smith.
- high frequency empha.
- Specifically for those inf reavirement.
- Ident for new hearing Aid users.
- Good for profound conductive.
- Good for profound conductive HL.
- Good for mild - severe HL' because gmn control can be manipulated to give less gain for those who don't need.
- Good.
- Appropriate for those with IHL exposed f CorHauces as well as ahrull Lord NCISP SIMUL HARDOubly.

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

Not Found

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

0

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. The eagle is composed of three curved lines that suggest movement and flight.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Martin Starkie Customer Service Representative AM Hearing Limited Faraday Road Crawley, West Sussex, England

Re:

OCT 2 8 1997

K973579 AM14, AM152AGC, AM152 , AGC-D, AM240PPL, AM240PPI, AM240HF, AM260AGC, AM260HF, AM2600HM, AM260K-AMP, AM260XP, AM262T-AGS, AM300XP, AM300AGC, AM300HF, AM300K-AMP, AM400PP, AM400PPL, AM500PP,AM510, AM530, AM550, AM800PPL, AM800T-AGS Hearing Aid Dated: September 19, 1997 Received: September 19, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Ms. Starkie:

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.

1

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro 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,

holliam Yi
Lillian Yi, 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

2

Page / of 2 3

510(k) Number (if known): 973 679

Device Name:_

Indications For Use:

1 5 5 4 - 1 3 2 3 - 1 2 - 1 2 - 1 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

A. General Indications:

The indication for use of the air conduction hearing aids in this the indication for ase of chool for individuals with impaired Submission is co ampirity bound rom for individuals with losses in nearing. The devices areas area. (Check appropriate space(s)):

Severity:	Configuration:	Other
X 1. Slight	1. High Frequency - Precipitously Sloping	1. Low tolerance To Loudness
X 2. Mild	X 2. Gradually Sloping	X 2. WITH LOUD INPUT LEVELS POSSIBLE
X 3. Moderate	3. Reverse Slope	3. DISTORTION
4. Severe	X 4. Flat	X High tolerance to Loudness
5. Profound	5. Other

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

3 .
l.

(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	K973579

3

Page 2 of 2 5

973579 K 510(k) Number (if known):

SUPP Device Name:

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). (Check appropriate space(s)):

Severity:	Configuration:	Other
_ 1. Slight	X 1. High Frequency - Precipitously Sloping	_ 1. Low tolerance To Loudness
_ 2. Mild	X 2. Gradually Sloping	X 2. High tolerance to Loudness
X 3. Moderate	_ 3. Reverse Slope	_ 3.
X 4. Severe	_ 4. Flat
_ 5. Profound	X 5. Other precipitous beginning @ 1KHz.

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

Good for patients with conductive HL.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Signature

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

510(k) Number	K973579
---------------	---------

4

Page 30f25

973 579 510(k) Number (if known):

Device Name: Sm 152 Alc

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this rne indication roamplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

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

B. Specific Indications (Only if appropriate.):

(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

Ideal for patients with sensorineural HL.
Good for those with narrow dynamic range

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

Concurrenge of CDRH, Office of Device Evaluation (ODE)

Varind A. Leyram

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K973579

5

Page 4 of 25

510(k) Number (if known):

Device Name: Am 152. AltC-1

Comments of the contract of the controlled to the many of the comments of the comments of the comments of the comments of the controlled of the comments of the comments of th

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). (Check appropriate space(s)):

Severity:		Configuration:		Other
	1. Slight		1. High Frequency - Precipitously Sloping		X1. Low tolerance To Loudness
X2. Mild		X2. Gradually Sloping		2.
X3. Moderate		3. Reverse Slope		3.
X4. Severe		X4. Flat
5. Profound		X5. Other precipitous from 1KHz ->

B. Specific Indications (Only if appropriate.):

(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

Ideal for patients with sensorineural HL.
Those who have A NARROW dynamic RANGE.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Lee Lynn
Division Sign-Off

Division of Reproductive, Abdominal, EN 510(k) Number

6

Page 5 of 25

510(k) Number (if known):

1 - 50 - 19 - 20 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Device Name:

K 973 579

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this
s of the same of the sound for individuals with impaired The indication for use of the arr condividuals with impaired submission is to amplify sound in individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices (is ) (Chock annonriate s hearing. The devices are Indicated for the "
the following category(ies). (Check appropriate space(s)):

Severity:
1. Slight
2. Mild
X3. Moderate
X4. Severe
X5. Profound
Configuration:
X1. High Frequency - Precipitously Sloping
X2. Gradually Sloping
X3. Reverse Slope
X4. Flat
X5. Other Scoop
Other
X1. Low tolerance To Loudness
X2. High tolerance to Loudness
3.

B. Specific Indications (Only if appropriate.): Citic Indications (on) it effress such as improved speech (Host psychoacouscic Indications buck to apported by clinical data.)

Good for severe - profound HL. whether conductive mixed or SNHL.

(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, and Radiological Dev 510(k) Number

7

Page 6 of 25

79 510(k) Number (if known):

Device Name: Am 2.4c PPi

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this
s of the life and for and for individuals with impaired The indication for use of the arr condividuals with impaired
submission is to amplify sound for individuals with loss submission is to amplify sound for individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices are indicated on arearia hearing. The devices are indicated as and the following category(s)):

Severity:

_ 1. Slight

_ 2. Mild

X 3. Moderate

X 4. Severe

_ 5. Profound

Configuration:

X 1. High Frequency

Precipitously Sloping

X 2. Gradually Sloping

_ 3. Reverse Slope

_ 4. Flat

X 5. Other: percipitous, scoop

Other

X 1. Low tolerance
To Loudness

X 2. High tolerance
to Loudness

_ 3.

B. Specific Indications (Only if appropriate.):

(Most psychoacoustic indications such as improved speech
intelligibility in background noise, must be supported by clinical

(Good for moderate - severe mixed or conductive HL.

2 .
data.)

3 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Kyson

Division Sign-Off) Division of Reproductive, Abdominal, EN

Restricted device (per 21 C

8

Page 7 of 25

AK

510(k) Number (if known):	K973579
---------------------------	---------

Ang 240 HFF Device Name:

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this ric indication is to amplify sound for individuals with impaired Submission is to any are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency - Precipitously Sloping X	1. Low tolerance To Loudness X
2. Mild	2. Gradually Sloping	2.
3. Moderate X	3. Reverse Slope	3.
4. Severe	4. Flat
5. Profound	5. Other precipitous @ 1.5K/Hz X

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

Bene

lits a mild-moderate sensorineura

3 .

(PLEASE DO NOT FRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division.co

Division of Reproductive, Abdominal, E and Radiological De

510(k) Number K0173579

9

Page & of 25

973579 510(k) Number (if known):

Device Name: Am 260 Ace

FOR CONSTITUTION PARTY OF CALL PROPERTY AND PRODUCT CONSULTERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this rne indication is to amplify sound for individuals with impaired Submission is to caps are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

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

Good for Sensorin

3 .

(PLEASE DO NOT GRITE BELOG THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973579

10

Page 9 of 25

		(
: ( BMOD	In and the many and in the Millionary 11, mall a work work works w

260 Device Name:

Indications For Use:

510(k) Number (if k

A. General Indications:

The indication for use of the air conduction hearing aids in this the indication to amplify sound for individuals with impaired Submission is to ampirity bound at the individuals with losses in
hearing. The devices are indicated for individuals and alle the following category(ies). (Check appropriate space(s)):

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

(-Good for SensoriNeural. hearing Loss.

3 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Waind. h. hyom
Division Sign Off

ivision Sign-Off) Division of Reproductive, Abdominal. B and Radiological I 510(k) Number

11

Page 10 of 2 5

973579 510(k) Number (if known):

Device Name: AM 260 CHM

THE CONTRACTOR COLLECTION CONSTITUTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CON

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The indication for ase of the Stor individuals with impaired Submission is co ampilly bound for andividuals with losses in nearing. The detect areas area. (Check appropriate space(s)):

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

B. Specific Indications (Only if appropriate.):

ic Indicatio (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

1 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vamk. li. Logson

(Division Sign-Off)

ivision of Reproductive, Abdominal, and Radiological D 510(k) Number

12

page 4 of 25

510(k) Number (if known):	K973579
---------------------------	---------

Device Name: AM 24c K-Amp

Comments of the state of the country of the in the state and the comments of the comments of the comments of the comments of the

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). (Check appropriate space(s)):

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.
3.

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

SPECIFICALLY FOR those with re
Ideal

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Urnit Co. Leigman

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Dev 510(k) Number

13

Page (2 of 25

| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) Number (if known): |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |

260 XF

Device Name:

1 - 19 1 2 3 3 3 3 3 3 2 2 2 1 2 2 1 1 2 1 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The indication for use of the arr condividuals with impaired
submission is to amplify sound for individuals with loss submission is to amplify sound for individuals with losses in
hearing. The devices are indicated for individuals with losses in
thearing. The devices (i ) (Check express hearing. The cevices are indicated aspropriate space(s)):
the following category(ies). (Check appropriate space(s)):

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

B. Specific Indications (Only if appropriate.): Citic Indications (oning such as improved speech intelligibility in background noise, must be supported by clinical

Good for mud-severe Sensorine

data.)

(PLEASE DO NOT FRITE BELOG 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

Labels	Values
510(k) Number	K913579

14

Pace / Sof 25

973579 510(k) Number (if known):

BECOME CONSTITUTION OF THE COLLECTION CONSULTION CANAL CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTIO

Device Name: An 2u TALS

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). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency

Precipitously Sloping | X 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | 3. Reverse Slope | 3. |
| X 4. Severe | 4. Flat | |
| 5. Profound | 5. Other precipitous beginning @ 1kHz -> | |

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

Appropriate HA for those exposed to
ConAnvous Mist as well as.
Short and Abrupt sudden Noises.

3 .

(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. K973579

15

Parcly of 25

510(k) Number (if known):

Device Name: frn 300 XP

Comprehender of the contraction of the services and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

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). (Check appropriate space(s)):

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	3.
✗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.)

MIN: Arukt l .

3 .

(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 2973579

16

page 15 of 25

4973579 510(k) Number (if known):

Device Name:

the state of the state of the same of the same of the many of the many of the management with and would and would and comment

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The Indication for asc of the of che of individuals with impaired Submission is to ampilly sound for individuals with losses in
hearing. The devices are indicated for succe(c)); nearing. The devices are mazers appropriate space(s)):

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

Miniature Size - Good for non-addicts
Good for Smith

3 .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

Division Sign-Off) ivision of Reproductive, Abdominal 510(k) Number

17

page // of 25

579 973 510(k) Number (if known)

Device Name:

The state of the may be and on the comments of the same of the many of the world of the many of the mail of the comments of the mail of the comments of the mail of the commen

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The indication for ase of the sound for individuals with loss submission is to amprily sound for individuals with losses in
hearing. The devices are indicated for individuals anaoo(s)); neating. The devices are = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

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

Configuration:
X 1. High Frequency - Precipitously Sloping
2. Gradually Sloping
3. Reverse Slope
4. Flat
5. Other

Other
1. Low tolerance To Loudness
X 2. high frequency empha
X 3. high tolerance to Loudness

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)

Elnid A. Seymm

(Division Sign-Off) Division of Reproductive, Abdomina

18

Parie /7 of 25

973 519 510(k) Number (if known):

Device Name: AAM 300 K-AMP

would and the controlled of the same of the comments of the most of the latest hands and

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The Indication for use of the stor individuals with Impaired submission IS to amprily sound for individuals with losses in
hearing. The devices are indicated for individuals ansoco(s)); nealing. "The devices are indestered appropriate space(s)):

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

B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (now poyendatoding in background noise, must be supported by clinical data.)

Specifically for those inf reavirement.
Ident for new hearing Aid users.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Seymour

(Division Sign-Off) Division of Reproductive, Abdomina 510(k) Numbe

19

Page 18 of 25

973579 510(k) Number (if known):

Device Name:

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). (Check appropriate space(s)):

Severity:	Configuration:	Other

Slight | 1. High Frequency

Precipitously Sloping | X 1. Low tolerance
To Loudness |
| 2. Mild | X 2. Gradually Sloping | X 2. High tolerance
to Loudness |
| X 3. Moderate | X 3. Reverse Slope | 3. ____________ |
| X 4. Severe | X 4. Flat | |
| X 5. Profound | X 5. Other (Scoop) | |

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

Good for profound conductive 9

(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 and Radiological I 510(k) Number

20

Page 4 of 25

510(k) Number (if known):	K 973 579
---------------------------	-----------

Device Name:

1 BS State 13 12 2 3 2 2 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

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). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency

Precipitously Sloping | X 1. Low tolerance
To Loudness |
| 2. Mild | X 2. Gradually Sloping | X 2. High tolerance to
LOUDNESS |
| X 3. Moderate | X 3. Reverse Slope | 3. ________ |
| X 4. Severe | X 4. Flat | |
| X 5. Profound | X 5. Other: Scoop | |

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

Good for profound conductive HL.

3 .

(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 K973579

21

Page 200f 25

510(k) Number (if known):	K973579
---------------------------	---------

International construction and the are and the are and the are a

Device Name:

and the started on the see of the promote of the comments of the same of the comment of concerners of concerners

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 bearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency - Precipitously Sloping	1. Low tolerance To LoudnessX
X2. Mild	X2. Gradually Sloping	2.
X3. Moderate	3. Reverse Slope	3.
X4. Severe	X4. 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.)

Good for mild - severe HL' because
gmn control can be manipulated
to give less gain for those who
don't need.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF HEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973579

22

Page 21 of 25

K 973 579 510(k) Number (if known):

ml 5/C) Device Name:___

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this The Indication for ase of cho of or individuals with impaired Submission is to ampilly sound for individuals with losses in
hearing. The devices are indicated for individuals with losses in nearing. The detegory(ies). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency

Precipitously Sloping | 1. Low tolerance
To Loudness |
| X 2. Mild | X 2. Gradually Sloping | X 2. high tolerance
to Loudness |
| X 3. Moderate | 3. Reverse Slope | 3. |
| 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 K973579

23

Page 920f 25

510(k) Number (if known):	K973579
---------------------------	---------

. STORES OF THE COLLECTION CONSULTION CONSULTION CONSULTERS CONSULTERS CONSULTERS CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTURAL CONSULTU

Device Name: _________________________________________________________________________________________________________________________________________________________________

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). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency - Precipitously Sloping	1. Low tolerance To Loudness
2. Mild	X2. Gradually Sloping	X2. High tolerance to Loudness
X3. Moderate	3. Reverse Slope	3.
X4. Severe	4. Flat
5. Profound	X5. Other precintous (@ 1KHz-on

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)

Eluned A. Kejosm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and.Radiological Dev 510(k) Number

24

Page 230f25

510(k) Number (if known):	K973579
---------------------------	---------

An 250 Device Name:

Indications For Use:

BE IT THE SECT FOR THE SERVED THE SECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTURAL CONSULTURAL

A. General Indications:

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired Submiories are indicated for indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:	Configuration:	Other
1. Slight	1. High Frequency - Precipitously Sloping	1. Low tolerance To Loudness
2. Mild	2. Gradually Sloping	X2. Keep tolerance to Loudness
3. Moderate	3. Reverse Slope	3.
X4. Severe	X4. 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)

of Reproductive, Abdominal, EN 510(k) Number

25

510(k) Number (if known):

FORMS 1893

Device Name:

Indications For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this rne indical is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

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

B. Specific Indications (Only if appropriate.):

1973 579

(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

Good

for

love

uctive /i.

(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 D 510(k) Number

26

Page 25 of 25

993379 510(k) Number (if known): 1800 1

Indications For Use:

Device Name:

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). (Check appropriate space(s)):

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

Configuration:
1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
X 5. Other Scoop

Other
X 1. Low tolerance To Loudness
2.
3.

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

Appropriate for those with IHL exposed
f CorHauces as well as ahrull Lord
NCISP SIMUL HARDOubly.

(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 K973579