(126 days)
The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-frequency hearing loss.
The Transcutaneous Titanium Tube System: has the start of a hearing system for adults with Mild to Moderate high-frequency hearing loss.
Mild to moderate high frequency hearing loss.
The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.
The provided text describes a medical device, the RetroX Titanium Tube System, and its 510(k) clearance application. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study results that would allow for the completion of the requested table and detailed study description.
The document primarily focuses on the regulatory aspects of the device, including:
- Device Description: The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-frequency hearing loss. It consists of a titanium tube placed via a "functional piercing" and a sound processor in the outer ear canal.
- Predicate Device: The RetroX TACHAS Titanium Tube System by Auric Hearing Systems (K013298).
- Intended Use: As a hearing system for adults with Mild to Moderate high-frequency hearing loss.
- Comparison Chart (Subject vs. Predicate Device): This chart details material, number of pieces, sizes, lengths, diameter, and how supplied, noting that the subject device (Gyrus ENT LLC) is sterilely supplied while the predicate device (Auric Hearing Systems, Inc.) is non-sterile. This comparison is for demonstrating substantial equivalence, not performance against specific criteria.
- FDA Clearance Letter: Confirms the 510(k) clearance (K040996) for the RetroX Titanium Tube System.
- Indications For Use: Mild to moderate high-frequency hearing loss.
Therefore, I cannot provide the requested table and study details because the necessary information is not present in the provided text.
To answer your request, I would need a document that includes sections on:
- Clinical study design and methodology
- Pre-specified acceptance criteria for device performance (e.g., audiometric thresholds, patient satisfaction scores, safety endpoints)
- Results from a study comparing the device's performance against these criteria
- Details about the ground truth, expert qualifications, sample sizes (training and test sets), and adjudication methods.
§ 874.3950 Transcutaneous air conduction hearing aid system.
(a)
Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA.” See § 874.1 for the availability of this guidance document.