Part 1: To develop a child friendly method to balance bilateral input with regard to loudness and to assess the effect of this so-called bilateral loudness balancing on speech perception in noise and localization. This child friendly method with…
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Part 1:
For optimal binaural hearing, balancing both devices (two cochlear implants
(CIs) for bilateral CI users and one CI and one hearing aid (HA) for bimodal
users) is of great importance. Differences in loudness level and arrival time
between the two ears are basal cues in sound source localization in the
horizontal plane. To improve interaural level difference (ILD) cues, it is
important that interaural loudness is balanced. In the current fitting
software, a method to perfectly balance both CIs is not available yet. The same
applies to balancing a CI and a HA for bimodal users.
Part 2:
In the Netherlands, a second CI is considered for children with a sensorineural
hearing loss of 85 dB HL or worse at 2 and 4 kHz. Worldwide, children with
congenital deafness are increasingly provided with BiCIs at a young age. But
what might bimodal children gain or lose after sequential bilateral cochlear
implantation? The answer to this question is becoming increasingly important,
because children with substantial residual hearing for the lower frequencies
are also considered for bilateral cochlear implantation, due to the current
hearing preservation techniques. To improve decision making and family
counselling with regard to bimodal or bilateral stimulation, it is important to
measure auditory outcomes in children with substantial residual hearing in the
non-implanted ear and compare the results with bilaterally implanted children,
both sequentially and simultaneously, and children with normal hearing.
Part 3:
Other important auditory factors are the changes in input dynamic range, smart
sound options and adaptive signal processing in CIs. To evaluate the effect of
fitting options, it is common to perform psychophysical experiments in adults
with cochlear implants. From our clinical experience it seems that the results
after cochlear implantation in adults are often different compared to that of
children implanted early in life. From a developmental point of view, it is
interesting to know what the effect of those options are in young children. For
children with the Cochlear Nucleus 6 sound processor and using adaptive
directionality (SCAN), the microphone switches from omnidirectional to
directional in noisy situations. The advantage of directional microphone
settings is better speech perception in noise when aiming at the target sound.
A disadvantage, however, might be that cues for directional hearing can be
distorted. Additionally, it might hinder incidental language learning in
children when speech is arriving from behind. In this side study the effect of
a directional microphone setting in children with BiCIs on their localization
skills and on speech recognition in noise will be investigated.
Study objective
Part 1: To develop a child friendly method to balance bilateral input with
regard to loudness and to assess the effect of this so-called bilateral
loudness balancing on speech perception in noise and localization. This child
friendly method with regard to loudness balancing will also be tested in
children with normal hearing.
Part 2: To assess the effect of sequential bilateral cochlear implantation in
children with a severe but well aidable hearing loss on the contralateral ear
compared to the effect of bimodal fitting in children with a comparable hearing
loss on primary auditory outcomes (i.e. speech recognition in noise, advanced
localization, prosody and listening effort) and compare those results with
congenitally deaf children with BiCIs implanted simultaneously and children
with normal hearing.
Part 3: To investigate the effect of a directional microphone setting in
children with BiCIs on their localization skills and on speech recognition in
noise.
Study design
Observational study
Study burden and risks
Subjects will be investigated one, two, three or four times, in which the risk
will be negligible and the burden for the subject will be very small. The study
takes place in minors as there are hardly any adult subjects available for
research, because bilateral cochlear implantation in adults is not reimbursed.
Furthermore, the outcomes after cochlear implantation in children and adults
are not fully comparable In the light of the clinical relevance of the study
towards the study population, we feel that the small burden is justified.
Philips van Leydenlaan 15 Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Philips van Leydenlaan 15 Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
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 (<18 months) as a reference;
Children with normal hearing as a reference;Part 3:
Children, age * 8 years old;
BiCIs implanted either simultaneously or sequentially;
NVA phoneme scores at 65 dB SPL of * 85% with bilateral cochlear implants.
Exclusion criteria
cognitive deficits;
learning deficits;
partial insertion of the CI.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL59997.091.16 |