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Bilateral or bimodal: fitting optimalization and the influence on primary auditory outcomes in cochlear implanted children

Bilateral or bimodal: fitting optimalization and the influence on primary auditory outcomes in cochlear implanted children - Bilateral or bimodal

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42981
Enrollment
70
Registered
2017-05-24
Start date
2018-04-12
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

deafness profound hearing loss

Interventions

None listed

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Part 1: Children, age * 8 years old; Bilateral stimulation (implanted either simultaneously or sequentially) and bimodal stimulation; NVA phoneme scores at 65 dB SPL of * 85% with bilateral cochlear implants; NVA phoneme scores at 65 dB SPL of * 85% with cochlear implant and * 50% with hearing aid in case of bimodal stimulation; Peers with normal hearing as a reference.;Part 2: Children, age * 8 years old; NVA phoneme scores at 65 dB SPL of * 85% best or only cochlear implant. Groups: Bimodal group: children with a cochlear implant and hearing aid with NVA phoneme scores at 65 dB SPL of *50% with the contralateral hearing aid; Bilateral group I: children with bilateral cochlear implants implanted sequentially, with substantial residual hearing on the secondly implanted side before surgery (NVA phoneme scores at 65 dB SPL * 50%); Bilateral group II: congenitally deaf children with bilateral cochlear implants, implanted simultaneously at a young age (

Exclusion criteria

Exclusion criteria: cognitive deficits; learning deficits; partial insertion of the CI.

Design outcomes

Primary

MeasureTime frame
Part 1: The difference in speech recognition in noise and localization acuity before and after loudness balancing with at least one month of adaptation. Part 2: The difference in primary auditory outcomes (i.e. speech recognition in noise, advanced localization acuity, prosody and listening effort) between children with BiCIs implanted sequentially and bimodally fitted children, both with well aidable hearing loss on the contralateral ear (prior to sequential bilateral cochlear implantation) and how these outcomes relate to those in children with BiCIs implanted simultaneously at a young age and children with normal hearing. Part 3: The difference in speech recognition in noise in two conditions (i.e. S0°N180° and S180°N0°) and localization acuity between a directional microphone and an omnidirectional microphone setting.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)