AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Device Facts
| Record ID | K971399 |
|---|---|
| Device Name | AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC |
| Applicant | General Hearing Instruments, Inc. |
| Product Code | ESD · Ear, Nose, Throat |
| Decision Date | Jun 13, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3300 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
To amplify and transmit sound to the ear.
Device Story
Auris series hearing aids (AE, TL, HS, AC, MM, COE, CIC) are air-conduction devices designed to amplify and transmit sound to the ear. Devices utilize DSD K-amp or Intrigue programmable circuitry to process sound based on individual audiogram requirements. Devices are assembled from standard components common to the hearing aid industry. Operated by the patient, the devices are worn in or on the ear (various form factors including all-in-the-ear, half-shell, and canal styles). Power is provided by standard batteries (sizes 13, 312, 10A, or 5A). Healthcare providers fit the devices by adjusting frequency response to match the patient's audiogram. The output provides amplification to assist patients with hearing loss. Users are advised of potential electromagnetic interference from digital cellular telephones.
Clinical Evidence
No clinical data provided; bench testing only. Technical specifications comply with S3.2-1987 ANSI Standards.
Technological Characteristics
All-in-the-ear, half-shell, and canal-style hearing aids. Programmable circuitry (DSD K-amp or Intrigue). Powered by standard batteries (13, 312, 10A, 5A). Technical specifications comply with S3.2-1987 ANSI Standards. Frequency response is customized via individual audiogram.
Indications for Use
Indicated for patients with mild to severe conductive, mixed, or sensoryneural hearing loss. Specific models indicated for cosmetic concerns (HS, MM, CIC, AC, TL) or specific high-frequency loss patterns (COE).
Regulatory Classification
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.
Submission Summary (Full Text)
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K971399
- TUN I 3 Nagt
NAME OF DEVICE: Auris AE
TYPE OF DEVICE: All-in-the-Ear
To amplify and transmit sound to the INTENDED USE : ear.
DSD K-amp or Intrigue programmable FEATURES : circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by FIT:
individual audiogram
Volume control similar to other devices. CONTROLS : Standard size 13 battery POWER :
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{1}------------------------------------------------
NAME OF DEVICE: Auris TL
TYPE OF DEVICE: All-in-the-Ear
To amplify and transmit sound to the INTENDED USE : ear.
DSD K-amp or Intrigue programmable FEATURES : ي تي پي په پ circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by FIT: individual audiogram Volume control similar to other devices. CONTROLS :
Standard size 312 battery POWER:
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{2}------------------------------------------------
NAME OF DEVICE: Auris HS
TYPE OF DEVICE: Half-shell-in-the-Canal
To amplify and transmit sound to the INTENDED USE : ear.
DSD K-amp or Intrigue programmable FEATURES : ﺔ ﺗﻮﻓﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by FIT: individual audiogram
Volume control similar to other devices. CONTROLS :
POWER: Standard size 312 battery
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{3}------------------------------------------------
NAME OF DEVICE: Auris AC
TYPE OF DEVICE: All-in-the-Canal
To amplify and transmit sound to the ear. INTENDED USE : DSD K-amp or Intrigue programmable FEATURES :
circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid ته ته ته ته ته ا manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications
comply with S3.2-1987 ANSI Standards"
Frequency response dictated by individual FIT: audiogram
Volume control similar to other devices. CONTROLS :
Standard size 312 battery POWER:
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{4}------------------------------------------------
NAME OF DEVICE: Auris MM
FIT:
TYPE OF DEVICE: Micro-Mini (All-in-the-Canal)
To amplify and transmit sound to the ear. INTENDED USE : DSD K-amp or Intrigue programmable FEATURES : circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications
comply with S3.2-1987 ANSI Standards"
Frequency response dictated by
individual audiogram
Volume control similar to other devices. CONTROLS :
Standard size 10A battery POWER:
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{5}------------------------------------------------
NAME OF DEVICE: Auris COE
TYPE OF DEVICE: Canal-Open-Ear (All-in-the-Canal)
To amplify and transmit sound to the INTENDED USE : ear.
DSD K-amp or Intrigue programmable FEATURES : نيو سي پيتي جي تي circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by FIT: individual audiogram
Volume control similar to other devices. CONTROLS : Standard size 10A battery POWER:
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{6}------------------------------------------------
NAME OF DEVICE: Auris CIC
TYPE OF DEVICE: Completely-in-the-Canal
To amplify and transmit sound to the ear. INTENDED USE :
DSD K-amp or Intrigue programmable FEATURES : ﻨﻲ circuitry
Assembled from standard components that ASSEMBLY : are widely used by other hearing aid manufacturers.
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3.2-1987 ANSI Standards" Frequency response dictated by individual FIT: audiogram
CONTROLS : Volume control similar to other devices.
POWER: Standard size 10a or 5a battery
A USERS' MANUAL AND OTHER INFORMATION
IS SUPPLIED WITH EACH HEARING AID.
{7}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### 1661 8 1 NUTT
Roger P. Juneau President General Hearing Instruments, Inc. -P.O. Box 61010 New Orleans, LA 70161-1010
学
Re: K971399
Programmable Option for Auris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris COE and CIC Air Conduction Hearing Aids Dated: April 25, 1997 Received: April 28, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Juneau:
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 exactment 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 ands, 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.
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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 ----------------------------------------------------"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
..............................................................................................................................................................................
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510(k) Number (if known): _K971399
Device Name: Auris AE-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to severe conductive, mixed or sensoryneural hearing loss
发:大
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Drive
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Harriet M. Bergman
ivision Sign-Off) · vision of Reproductive, Abdominal, ENT, d Radiological Devices 0(k) Number _
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Page 2_of_7
510(k) Number (if known): K971399
Device Name: Auris HS-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Seine
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Schmidt Ch. Sejrem
(Division Sign-Off)
( - Choice Of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Device
510(k) Number K971344
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Page 3 of 7
510(k) Number (if known): _K971399
Device Name: Auris MM-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Service
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Clifford W. Kellison
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K9711394
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Page 4 of 7
510(k) Number (if known): K971399
Device Name: Auris CIC-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
乐心--
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Service
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
Varick A. Wynen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number _
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Page 5_of _
510(k) Number (if known):_K971399
Device Name: Auris TL-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
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# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Sample. \$\checkmark\$
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Daniel C. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
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510(k) Number (if known): _K971399
Device Name: Auris AC- (DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
ﺮ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Device
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
David A. Siyonn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
{15}------------------------------------------------
510(k) Number (if known):_K971399
Device Name: Auris COE-(DSD K-amp) or (Intrigue-Pro) Option
Indications For Use:
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
4
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted Device ✓
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Daniel A. Lippman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
