(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.
§ 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.