Clinical Trials Directory

Trials / Completed

CompletedNCT04559282

Home Test of New Sound Processor

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Cochlear · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENew Sound ProcessorThe 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.

Timeline

Start date
2020-09-23
Primary completion
2020-11-27
Completion
2020-11-27
First posted
2020-09-22
Last updated
2021-11-22
Results posted
2021-11-22

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04559282. Inclusion in this directory is not an endorsement.