(77 days)
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are not an issue.
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss when the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue.
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are a major issue.
Tranquil TRI-OE: I-T-E hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 312 battery.
Tranquel TRI-COE: I-T-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.
Tranquel TRI-CIC: C-I-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.
The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such a study.
The documents are a 510(k) summary of safety and effectiveness information for the "Tranquil TRI-OB, TRI-COE & TRI-CIC Tinnitus Maskers / Hearing Aids". This type of submission is for demonstrating
substantial equivalence to a predicate device already legally marketed, rather than proving performance against novel acceptance criteria through a specific study.
Here's what the documents do provide:
- Intended Use: A hearing Aid and/or Tinnitus Masker/Habituator for patients with no hearing loss or mild to severe high-frequency hearing loss, where the patient's response to tinnitus is characterized by intolerance, specifically the inability to cope with head noises, anxiety, depression, or inability to function in daily life activities. The "Tranquil TRI-OE" is for when cosmetics are not an issue, "Tranquil TRI-COE" for when cosmetics are an issue, and "Tranquil TRI-CIC" for when cosmetics are a major issue.
- Technical Characteristics: "Technical specifications comply with S3 2-1987 ANSI Standards." This is the closest thing to an acceptance criterion mentioned, but it refers to a general standard compliance rather than specific performance metrics unique to this device.
- Device Features: Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable.
- Assembly: Assembled from standard components widely used by other hearing aid manufacturers.
- Regulatory Classification: Class III, Procode: 77 KLW/77 ESD, under 21 CFR 874.3400/21 CFR 874.3300.
- Substantial Equivalence: The FDA letter (Document 3) explicitly states that the device is found to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This is the basis for its clearance, not a new performance study.
Therefore, based on the provided text, I cannot answer the questions about acceptance criteria, a specific study, sample sizes, ground truth, or expert involvement because this information is not present in a 510(k) summary demonstrating substantial equivalence. Such details would typically be found in detailed clinical trial reports or design verification/validation documents, which are not part of this submission.
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q74751
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NAME OF DEVICE: Tranquil™ TRI-OE MAR - 6 1998 TYPE OF DEVICE: I-T-E
INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,
DSD K-amp programmable or Intrigue Programmable ASSEMBLY: Assembled from standard components that are widely used by other hearing aid manufactures
"Technical specifications TECHNICAL CHARACTERISTICS: comply with S3 2-1987 ANSI Standards"
FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic Standard Size 312 battery POWER:
A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.
ATTACHMENT I
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A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NAME OF DEVICE: Tranquel TRI-COE
TYPE OF DEVICE: I-T-C
INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,
DSD K-amp programmable or Intrigue Programmable ASSEMBLY: Assembled from standard components that are widely
used by other hearing aid manufactures TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3 2-1987 ANSI Standards"
FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic Standard Size 10A battery POWER:
A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.
ATTACHMENT I
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A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NAME OF DEVICE: Tranquel TRI-CIC
TYPE OF DEVICE: C-I-C
INTENDED USE: A hearing Aid and/or Tinnitus Masker/Habituator FEATURES: Class A Noise Generator, Class D Noise Generator,
DSD K-amp programmable or Intrigue Programmable
ASSEMBLY: Assembled from standard components that are widely used by other hearing aid manufactures
TECHNICAL CHARACTERISTICS: "Technical specifications comply with S3 2-1987 ANSI Standards"
FIT: Frequency response dictated by individual audiogram CONTROLS: Volume control mechanical or electronic
Standard Size 10A battery POWER:
A USERS' MANUAL AND OTHER INFORMATION IS SUPPLIED WITH EACH MASKER/HEARING AID.
ATTACHMENT I
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 6 1998
Roger P. Juneau President General Hearing Instruments, Inc. P.O. Box 23748 New Orleans, LA 70183-0748
Re: K974751
Tranquil TRI-OB, TRI-COE & TRI-CIC Tinnitus Maskers /Hearing Aids Dated: December 17, 1997 Received: December 19, 1997 Regulatory class: III 21 CFR 874.3400/21 CFR 874.3300 Procode: 77 KLW/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 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 Eederal 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.
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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,
William Yi
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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3 Page 1 of
510(k) Number (if known): K97475
Tranqui1 tm TRI-OE Device Name:
Indications For Use:
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low nearing foss where the patient the patient's response. to tinnitus is characterized by intolerence. to cinnitus is charactlity to cope with head noises , Specifically the Thability of offer to function in daily life activities . When cosmetics are not an issue.
(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,
Radiological Devices
510(k) Number K974757
Prescription Use Y (Per 21 CFR 801.109)
೧೫
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Restricted Device
Per 874.420 and 421
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Page_2_ _of_3
510(k) Number (if known): 1497475 L
Device Name: Tranqui 1 tm TRI-COE
Indications For Use:
No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low nearing foss when the patient's response. to tinnitus is characterized by intolerence. co cifically the inability to cope with head noises . Specifically the rhability to objection news.
anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sion-Off) of Reproductive. Abdominal. ENT.
Prescription Use
(Per 21 CFR 801.109)
ેવાયું છત્વ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
icted De if 874.420 and 4
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510(k) Number (if known): प्रिं९७४७ ५८
Device Name: Iranqui] tm IRI-CIC
Indications For Use:
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low nearing ross there the patient's response. to tinnitus is characterized by intolerence. to cifically the inability to cope with head noises, Specifically chevro or the inability to function in daily life activities. When cosmetics are a major issue.
(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, EN and Radiological Devices
510(k) Number K974727
Prescription Use (Per 21 CFR 801.109)
ભિ
Over-The-Counter Use ..........
(Optional Format 1-2-96)
Restricted Device Per 874.420 and 421
§ 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.