At a glance
ClinicalIndex Comparison RecordN/ACompleted· 16 enrolled
Drug / intervention
New Sound Processordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss
In Brief
A clinical study evaluating New Sound Processor for Hearing Loss. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesSweden
CollaboratorsStatistiska Konsultgruppen
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartSep 2020
Primary CompletionNov 2020
TodayJul 2026
First PostedSep 22, 2020
Enrollment StartSep 23, 2020
Primary CompletionNov 27, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.8 years ago
Interventions
New Sound Processordevice
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.