K223848 is an FDA 510(k) clearance for the Intrisound™ Tuned Lumen® 155 Hearing Aids. Classified as Self-fitting Air-conduction Hearing Aid, Over The Counter (product code QUH), Class II - Special Controls.
Submitted by Tuned , Ltd. (Gan Yoshiya, IL). The FDA issued a Cleared decision on September 8, 2023 after a review of 260 days - an extended review cycle.
This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3325 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.
View all Tuned , Ltd. devices
NCT05869266
Completed
Interventional
Industry-sponsored
Tuned App Self-Fitting vs. Professional Fitting
A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting
| Condition studied |
Hearing Loss |
| Study design |
Crossover |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Leonid Kriksunov |
| Sponsor |
Tuned Ltd.
(industry)
|
Started 2023-05-01
→
Primary completion 2023-07-01
→
Completed 2023-07-15
Primary outcome
Comparison of self fitting and professional fitting by COSI scores
Secondary outcome
Comparison of self fitting and professional fitting by IOI-HA scores
Study completed - no results published.
This trial concluded in 2023 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov