Skip to content

Bilateral Cochlear Implantation Benefits in Adult Users of the HiRes 90K Bionic Ear System

Bilateral Cochlear Implantation Benefits in Adult Users of the HiRes 90K Bionic Ear System - Bilateral Cochlear Implantation (RCT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33681
Enrollment
48
Registered
2008-11-10
Start date
2009-12-11
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deaf SNHL

Interventions

Sponsors

Advanced Bionics Europe
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with bilateral sensorineural hearing loss of a severe or greater degree and with postlingual onset

Exclusion criteria

Exclusion criteria: Previous cochlear implant experience, abnormal cochlear anatomy, non-fluent in Dutch, disabilities which could interfere with the tests.

Design outcomes

Primary

MeasureTime frame
Evaluate the benefits adults obtain from bilateral versus unilateral cochlear implant use. Compare bilateral cochlear implant benefit after simultaneous versus sequential implantation Primary parameter: Performance on hearing in noise test with sentences in Dutch (Objective).

Secondary

MeasureTime frame
Evaluate the benefits adults obtain from bilateral versus unilateral cochlear implant use. Compare bilateral cochlear implant benefit after simultaneous versus sequential implantation Secundary parameters: Objective: Performance on Standard Dutch phoneme test (NvA-list, Bosman), Performance on Speech intelligibility with spatially separated sources, Performance on Crescent of sound tests (Quentin Summerfield) Subjective: Self-reported benefits in everyday listening situations assessed with the Speech, Spatial and Qualities Hearing Scale (SSQ), Quality-of-life questionnaire scores, Tinnitus questionnaire scores.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)