Directional Microphone Systems for Bimodal Listeners

Directional Microphone Systems for Bimodal Listeners - Bimodal Zoom

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43822

Enrollment

Registered

2015-01-28

Start date

2015-03-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

deafness profound sensorineurinal hearing loss

Interventions

During a test session subjects are provided with the latest speech processor for the CI and when applicable a state-of-the-art hearing aid allowing different microphone configurations: standard omni

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Bimodal group: In order to be eligible to participate in the bimodal group of this study, a subject must meet all of the following criteria: * capacitated adult (>18 years of age) * patient of CI-team South-East Netherlands * user of a unilateral cochlear implant (CI) of the brand Advanced Bionics (AB) * first fit CI >50% of the time (i.e. circa 5 hours a day) * able to perform the speech-in-noise test (i.e. speech recognition in quiet >50%) * willing and able to visit the azM and participate in testing * agreed to participate in this study (by informed consent);Bilateral group: In order to be eligible to participate in the bilateral group of this study, a subject must meet all of the following criteria: * Capacitated adult (>18 years of age) * Patient of CI-team azM, RadboudUMC or UMCU * Former subject in the study *Bilateral Cochlear Implantation Benefits in Adult Users of the HiRes(R) * 90K Bionic Ear System* (NL24660.018.08/NTR1722) who completed the full follow-up period of four years since the first implantation * User of bilateral cochlear implants (CI*s) of the brand Advanced Bionics (AB) * First fit of second CI *50%) * Willing and able to visit the azM and participate in testing * Agreed to participate in this study (by informed consent);And additionally in the case of a patient of CI-team UMCU or RadboudUMC: * Agreed to let the research team of the current study inform the own CI-team respectively of his/her participation in the current study (by informed consent) * Agreed to let the research team of the current study retrieve his/her basic audiological information from the CI-team UMCU or RadboudUMC (by informed consent)

Exclusion criteria

Exclusion criteria: Bimodal group: A potential subject who meets any of the following criteria will be excluded from participation in the bimodal group: * non fluent in Dutch *

Design outcomes

Primary

Measure	Time frame
The primary outcome is the effect of microphone configuration on speech recognition performance in noise. Two main effects are distinguished: - Symmetric directional benefit, defined as the difference between the standard omnidirectional configuration, and the directional multi-microphone system in both CI and HA. - Asymmetric effect, defined as the difference between a symmetric (directional multi-microphone system in both CI and HA) and an asymmetric directional configuration (standard omnidirectional microphone in HA and directional multi-microphone system in CI). With the amendment "Binaural Beam" the following primary study parameters were added: - Symmetric binaural directional benefit, defined as the difference between the omnidirectional configuration and the binaural beamforming system when listening with both CI and HA. - Asymmetric binaural directional benefit, defined as the difference between the omnidirectional configuration and the binaural beamforming system when listening with CI alone. With the amendment "Bilateral Zoom" the following primary study parameters were added: - Bilateral monaural directional benefit, defined as the difference between the standard omnidirectional configuration and the monaural beamforming system when listening with two CIs. - Bilateral binaural directional benefit, defined as the difference between the standard omnidirectional configuration (test condition 1) and the binaural beamforming system (test condition 3) when listening with two CIs.	—

Measure

Time frame

The primary outcome is the effect of microphone configuration on speech recognition performance in noise. Two main effects are distinguished: - Symmetric directional benefit, defined as the difference between the standard omnidirectional configuration, and the directional multi-microphone system in both CI and HA. - Asymmetric effect, defined as the difference between a symmetric (directional multi-microphone system in both CI and HA) and an asymmetric directional configuration (standard omnidirectional microphone in HA and directional multi-microphone system in CI). With the amendment "Binaural Beam" the following primary study parameters were added: - Symmetric binaural directional benefit, defined as the difference between the omnidirectional configuration and the binaural beamforming system when listening with both CI and HA. - Asymmetric binaural directional benefit, defined as the difference between the omnidirectional configuration and the binaural beamforming system when listening with CI alone. With the amendment "Bilateral Zoom" the following primary study parameters were added: - Bilateral monaural directional benefit, defined as the difference between the standard omnidirectional configuration and the monaural beamforming system when listening with two CI*s. - Bilateral binaural directional benefit, defined as the difference between the standard omnidirectional configuration (test condition 1) and the binaural beamforming system (test condition 3) when listening with two CI*s.

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Secondary

Measure	Time frame
Secondary outcomes in this study are: - Asymmetric directional benefit, defined as the difference between the standard omnidirectional configuration in both CI and HA, and an asymmetric directional configuration (standard omnidirectional microphone in HA and directional multi-microphone system in CI). - Effect of masker type, defined as the performance difference between a stationary speech-shaped background noise and a fluctuating competing talker. - Listening effort, defined as the effort it takes to listen to speech in noise in the different directional and masking conditions. With the amendment "Binaural Beam" the following secondary study parameters were added: - Omnidirectional bimodal benefit, defined as the difference between hearing with both CI and HA in the omnidirectional mode compared to listening with only a CI in omnidirectional mode. - Binaural directional bimodal benefit, defined as the difference between hearing with both CI and HA when binaural beamforming is activated compared to listening with only a CI when binaural beamforming is activated. With the amendment "Bilateral Zoom" the following secondary study parameter was added: - Bilateral pinna effect, defined as the difference between the pure omnidirectional configuration and the pinna located standard omnidirectional configuration when listening with two CI*s.	—

Measure

Time frame

Secondary outcomes in this study are: - Asymmetric directional benefit, defined as the difference between the standard omnidirectional configuration in both CI and HA, and an asymmetric directional configuration (standard omnidirectional microphone in HA and directional multi-microphone system in CI). - Effect of masker type, defined as the performance difference between a stationary speech-shaped background noise and a fluctuating competing talker. - Listening effort, defined as the effort it takes to listen to speech in noise in the different directional and masking conditions. With the amendment "Binaural Beam" the following secondary study parameters were added: - Omnidirectional bimodal benefit, defined as the difference between hearing with both CI and HA in the omnidirectional mode compared to listening with only a CI in omnidirectional mode. - Binaural directional bimodal benefit, defined as the difference between hearing with both CI and HA when binaural beamforming is activated compared to listening with only a CI when binaural beamforming is activated. With the amendment "Bilateral Zoom" the following secondary study parameter was added: - Bilateral pinna effect, defined as the difference between the pure omnidirectional configuration and the pinna located standard omnidirectional configuration when listening with two CI*s.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)