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The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

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The provided document is a 510(k) substantial equivalence letter for the "Tranquil TRI-BTE" Tinnitus Masker. This type of letter does not typically contain detailed information about acceptance criteria or specific study protocols and results for device performance. It confirms that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

Therefore, based on the content of the provided document, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on the regulatory determination of substantial equivalence and general requirements for marketing the device.

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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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Mild to severe conductive, mixed or sensoryneural hearing loss
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
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
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
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.
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.

To amplify and transmit sound to the ear.
DSD K-amp or Intrigue programmable circuitry
Assembled from standard components that are widely used by other hearing aid manufacturers.
"Technical specifications comply with S3.2-1987 ANSI Standards"
Frequency response dictated by individual audiogram
Volume control similar to other devices.
Standard size 13 battery
Standard size 312 battery
Standard size 10A battery
Standard size 10a or 5a battery

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Auris hearing aids. The documents describe different models of Auris hearing aids, their intended use, features, technical characteristics, and the FDA's 510(k) clearance approval, but they do not include any specific clinical study data or performance metrics against defined acceptance criteria.

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