LogoFDA 510(k) Search
K Number
K971807
Device Name
IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
Manufacturer
HEAR-RIGHT, INC.
Date Cleared
1997-08-07

(84 days)

Product Code
ESD
Regulation Number
874.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (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
More Information

Not Found

Not Found

No
The provided text explicitly states "Mentions AI, DNN, or ML: Not Found" and there are no other indicators of AI/ML technology in the description.

Yes
The device is a hearing aid, which amplifies sound for individuals with impaired hearing. Hearing aids are considered therapeutic devices as they treat hearing loss.

No
The device is described as an "air conduction hearing aid" intended to "amplify sound for individuals with impaired hearing." Its function is to assist hearing, not to diagnose a medical condition.

No

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

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The provided information describes air conduction hearing aids. These devices amplify sound to help individuals with impaired hearing. They interact with the external environment (sound waves) and the ear, not with samples taken from the body.
  • Intended Use: The intended use is to "amplify sound for individuals with impaired hearing," which is a therapeutic/assistive function, not a diagnostic one performed on a biological sample.

Therefore, based on the provided information, this device falls under the category of a medical device, but specifically a hearing aid, not an in vitro diagnostic.

N/A

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: Mild, Moderate
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat
Other: Low tolerance To Loudness

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
Configuration: Gradually Sloping, Flat

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
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat
Other: Low tolerance To Loudness

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
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat
Other: Low tolerance To Loudness

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
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Flat
Other: Low tolerance To Loudness

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

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

77 ESD

Device Description

Not Found

Mentions image processing

No

Mentions AI, DNN, or ML

No

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

§ 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.

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):K97/807Page 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 Sloping2. __________
✓ 3. Moderate3. Reverse Slope3. __________
4. Severe✓ 4. Flat
5. Profound5. 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)

3

510(k) Number (if known)K971807Page 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. Slight1. 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) | |

4

510(k) Number (if known):K971807Page 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. Slight1. High Frequency - Precipitously Sloping1. Low tolerance To Loudness
2. Mild2. Gradually Sloping2.
3. Moderate3. Reverse Slope3.
4. Severe4. Flat
5. Profound5. 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:

j

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. ProfoundConfiguration:___ 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):K971807Page 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. Slight1. 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 | |

7

Face of //

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

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

Indi ations For Use:

A. Guneral 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 tollowing category(1es). (Check appropriate space(s));

Severity:Configuration:Other
1. Slight1. 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)

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. Slight1. High Frequency - Precipitously Sloping1. Low tolerance To Loudness
2. Mild2. Gradually Sloping2.
3. Moderate3. Reverse Slope3.
4. Severe4. Flat
5. Profound5. 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:

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 Sloping2. __________
✓ 3. Moderate3. Reverse Slope3. __________
☐ 4. Severe✓ 4. Flat
☐ 5. Profound5. 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) NumberK971807
------------------------

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:

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 tollowing category(ies). (Check appropriate space(s)):

Seve ity:Configuration:Other
1. Slight✓ 1. High Frequency - Precipitously Sloping1. Low tolerance To Loudness
2. Mild✓ 2. Gradually Sloping2. ___________
✓ 3. Moderate✓ 3. Reverse Slope3. ___________
✓ 4. Severe✓ 4. Flat
5. Profound5. 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):K971807Page 10 of 11
Device Name:Eagle ITE K-Amp (EK)
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 Sloping2. __________
✓3. Moderate_3. Reverse Slope3. __________
_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)

:

、

l

: :

:

:

:

12

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

Page 1 of 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. Slight1. High Frequency - Precipitously Sloping1. Low tolerance To Loudness
2. Mild2. Gradually Sloping2. __________
3. Moderate3. Reverse Slope3. __________
4. Severe4. Flat
5. Profound5. 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)