At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
In Brief
A clinical study evaluating Audiometry for Hearing Loss, Conductive and Hearing Loss, Mixed. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019. Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics. The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.
Study Details
Timeline
Interventions
Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit. Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)). Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off.