An interventional study of Hearing aid: Phonak Audéo B90-Direct in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.
1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 778 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 88 studies on the registry; 6 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants fulfilling all of the following inclusion criteria are eligible for the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
Traditional standard fitting method which do not include adjustments from the participants.
Device: Hearing aid: Phonak Audéo B90-Direct
Alternative fitting method which includes additional adjustments from the participants.
Device: Hearing aid: Phonak Audéo B90-Direct
Hearing aids will be fitted to the participants individual hearing loss.
Comparison of fitting method A versus B in regard to sound quality
The number of subjects who prefer the hearing aid setting achieved with hearing aid fitting method A versus B will be measured in the lab with the aid of sounds presented via loudspeakers. This will be measured with the Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) method.
Time frame: 2 months
Comparison of fitting method A versus B in regard to speech intelligibility in noise
The speech intelligibility in noise with hearing aid fitting method A versus B will be measured with the aid of the Oldenburg sentence test in dB Speech Reception Treshold (SRT).
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Jan 2019, 3 months.
Of 176 industry-sponsored interventional studies with no phase under Hearing Loss, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 3 months is below that.
Counting every sponsor, half of 444 studies reached it within 17 months; a quarter within 5 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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