An interventional study of Extension of Virto B-Titanium and Virto B-Titanium in Hearing Loss, Sensorineural, sponsored by Sonova AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Sonova AG · Not applicable, Interventional, and Treatment
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
375 studies on the registry are indexed under Hearing Loss, Sensorineural; 108 are open to participants now.
This study's enrollment of 16 is below the median of 32 across 266 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural 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.
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Exclusion Criteria:
The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Device: Extension of Virto B-Titanium
The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Device: Virto B-Titanium
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
Visibility and Wearing Comfort
The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
Time frame: 3 weeks
Measurement of acoustic Feedback Thresholds
Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain \[in dB SPL\] of at least 20 dB in a specific frequency range.
Time frame: 3 weeks
TFG Fitrate
Another objective is to investigate whether at least 50% of the screened population will get a deeper fitted device by the use of the TFG tool, proven by modelling software
Time frame: 3 weeks
Ran from May 2018 to primary completion in Jun 2018, 1 month.
Of 83 industry-sponsored interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 23. This study's 1 month is below that.
Counting every sponsor, half of 166 studies reached it within 21 months; a quarter within 6 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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