IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL by HEAR-RIGHT, INC.

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: Slight, Mild, Moderate, Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other. Other: Low tolerance To Loudness.

Device Description

Not Found

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the documents {0}, {1}, {2}, {3}, {4}, {5}, {6}, {7}, {8}, {9}, {10}, {11}, and {12} are composed of:

A letter from the FDA (K971807 decision letter): This letter serves as notification that the FDA has reviewed the Section 510(k) notification for the Hear-Right Hearing Aids (models Hidden CIC, Cardinal ITC, Eagle ITE) and determined them to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This letter emphasizes that it allows the company to begin marketing the device, subject to general controls. It also includes a warning about potential electromagnetic interference from digital cellular phones.
Multiple "Indications for Use" forms (K971807, Pages 1-12 of 11 in total which is wrong, also 1,2,3... of 1 for some pages, meaning a general confusion and bad structure): These forms detail the general and specific indications for different models of Hear-Right hearing aids. The general indication is to "amplify sound for individuals with impaired hearing." They also specify categories of hearing loss severity (slight, mild, moderate, severe, profound), configuration (high frequency, precipitously sloping, gradually sloping, reverse slope, flat, other), and other conditions (low tolerance to loudness). Notably, section B states: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)"

Since the document provided is a 510(k) clearance letter and associated indications for use, it primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria as would be found in a clinical trial report.

Therefore, I cannot extract the requested information based on the provided text. To answer your questions, the following would need to be present in the document:

A table of acceptance criteria and the reported device performance: This document does not present any quantitative performance metrics or specific acceptance criteria.
Sample size used for the test set and the data provenance: Not mentioned. The 510(k) relies on substantial equivalence to predicate devices, not typically a new test set for primary performance claims.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned as there's no mention of a test set with established ground truth.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hearing aid, not an algorithm.
The type of ground truth used: Not applicable, as no ground truth is explicitly discussed for performance evaluation.
The sample size for the training set: Not applicable, no training set or algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1997

Craig Bloomingburg¨¨ President Hear-Right, Inc. 2606 Villa Prom Suite 74 Oklahoma City, OK 73107 Re: K971807 ·

Hear-Right Hearing Aidsl; Models: Hidden CIC (HP, HL, HK, H JC), Cardinal ITC (CP, CL. CK) Eagle ITE (EP, EL, EK, EB) Dated: May 8, 1997 Received: May 15, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD

Dear Mr. Bloomingham:

We have reviewed your Section 510(k) notification of intent to market the device 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 decined substantially cquivalent to cities 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 incffective for the wearer. Because clectromagnetic 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 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,

Nillian Yhi

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}------------------------------------------------

510(k) Number (if known):	K97/807	Page 1 of 11
Device Name:	Hidden CIC K-Amp Programmable (HP)
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.)
	1. __________
	2. __________
	3. __________

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

<img src="data:image/png;base64,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ك

{3}------------------------------------------------

510(k) Number (if known)	K971807	Page 2 of 11
Device Name:	Nidden Linear CIC (NL)
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 toleranceTo 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.)
1.
2.
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	K971807
	Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

{4}------------------------------------------------

510(k) Number (if known):	K971807	Page 3 of 4
Device Name:	Hidden K-amp CIC (HK)
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.)
	1.
	2.
	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 K971807
	Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

{5}------------------------------------------------

S10 (i: ) Number (if known) : _

page 4 of //.

Device Name: Hidden IC CIC (HIC).

Indication; For Use:

A. General Indications:

The indication for use of the air conduction hearing aids in this submission is to smplify sound for individuals with impaired Submission is co implicated for individuals with losses in neering. Ing category(ies). (Check appropriate space(s)):

Seve ity:	✓ 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.)

(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 and Radiological Devio

510(k) Number KG71807

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

{6}------------------------------------------------

510(k) Number (if known):	K971807	Page 5 of 11
Device Name:	Cardinal ITC K-Amp Programmable (CP)
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 toleranceTo 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.)
	1. ______
	2. ______
	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 K971807

{7}------------------------------------------------

Face of //

510(::) Number (if known): K9711807

( C ) L C ( C Linear ( C ) Device Nami:

Indi ations For Use:

A. Guneral Indications:

Severity:	Configuration:	Other
1. Slight	1. High Frequency- Precipitously Sloping	1. Low toleranceTo 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.)

(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 K971807
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)

{8}------------------------------------------------

page 2 of 11.

510(k) Number (if known):	K97/807
---------------------------	---------

Device Name: Cardinal ITC K-Amp (CK)

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.)

(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 K971807

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

{9}------------------------------------------------

510(k) Number (if known):	K971807
---------------------------	---------

Page 8 of 11

Device Name:	Eagle ITE K-Amp Programmable (EP)
--------------	-----------------------------------

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	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.)

(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	K971807
---------------	---------

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

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

{10}------------------------------------------------

510(i:) Number (if known): 5971807

Page 9 of 11

Device Name: Eagle IR Linear (EL)

Indi:ation;; For Use:

A. General Indications:

Seve ity:	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.)

(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 KG71807

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

{11}------------------------------------------------

510(k) Number (if known):	K971807	Page 10 of 11
Device Name:	Eagle ITE K-Amp (EK)
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	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.)

(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 K971807

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

、

: :

{12}------------------------------------------------

510(k) Number (if known):	K971807
Device Name:	Eagle ITE Push/Pull (EB)

Page 1 of 1

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	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.)

(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 K971802

Restricted device (per 21 CPK 801.420 & 21 CPR 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.