Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients

Study Overview
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Brief Summary
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Communication on telephone is challenging for people with hearing loss. For hearing aid users, for instance, the inventions for improving speech intelligibility on the phone range from an integrated tele coil and individual hearing programs to specially designed phone devices. No formal studies involving these devices have been carried out with CI users. Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate different hearing solutions for communication on telephone in terms of intelligibility and ease of use.

Detailed Description
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Communication on telephone is challenging for people with hearing loss, due to a number of factors: The lack of visual cues (lip-reading), The lack of binaural abilities, The presence of (loud) background noise in a variety of listening situations, A modified speech signal due to reduced frequency bandwidth and Difficulties coupling the phone to the CI. For hearing aid users, for instance, the inventions for improving speech intelligibility on the phone range from an integrated tele coil and individual hearing programs to specially designed phone devices. No formal studies involving these devices have been carried out with CI users. Thus, this comparative study includes hearing aid as well as CI and bimodal users to evaluate the different hearing solutions for communication on telephone in terms of intelligibility and ease of use: Phonak DECT - cordless telephone for HA-, CI- users and bimodal users Phonak EasyCall - accessories for Bluetooth capable mobile telephones for HA-, CI- and bimodal users Phonak DuoPhone - streaming function, which provides the speech signal to both ears

Official Title
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Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients

Conditions
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Hearing Loss, Binaural, Hearing Loss, Monaural

Intervention / Treatment
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* Device: standard telephone setting
* Device: DECT
* Device: EasyCall
* Device: DuoPhone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral HA users with SRT of better (lower) than + 3 dB Bilateral HA users with SRT of better (lower) than 0 dB Unilateral CI users: Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant 1-year acclimatization time after implantation at least 20% correct for a sentence test delivered with a SNR of + 10 dB, or a SRT of better (lower) than + 15 dB Bimodal (CI + HA) users: Unilaterally implanted with an Advanced Bionics CII, HiRes90k or Advantage implant CI side: at least 20% correct for a sentence test delivered with a SNR of + 10 dB, or a SRT of better (lower) than + 15 dB HA side: unaided threshold ≤ 80 dB at least for frequencies up to 500 Hz All users: Informed Consent as documented by signature Ability for speech understanding in the presence of competing noise without any assistance from lip-reading Ability to give subjective feedback in a certain listening situation First language: German or Swiss-German Exclusion Criteria: All users: Difficulties additional to hearing impairment that would interfere with the study procedures Acute inflammation or pain in head-/neck area Dizziness Age of participants < 18 years Age of participants > 80 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bimodal user<br>wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone | Device: standard telephone setting<br>* without streaming function<br>Device: DECT<br>* cordless telephone (streaming to both hearing devices)<br>Device: EasyCall<br>* accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)<br>Device: DuoPhone<br>* streaming function, which provides the speech signal to both ears<br>|
| Other: unilateral hearing aid users<br>wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone | Device: standard telephone setting<br>* without streaming function<br>Device: DECT<br>* cordless telephone (streaming to both hearing devices)<br>Device: EasyCall<br>* accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)<br>|
| Other: bilateral hearing aid users<br>wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone | Device: standard telephone setting<br>* without streaming function<br>Device: DECT<br>* cordless telephone (streaming to both hearing devices)<br>Device: EasyCall<br>* accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)<br>Device: DuoPhone<br>* streaming function, which provides the speech signal to both ears<br>|
| Other: CI users<br>wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone | Device: standard telephone setting<br>* without streaming function<br>Device: DECT<br>* cordless telephone (streaming to both hearing devices)<br>Device: EasyCall<br>* accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)<br>Device: DuoPhone<br>* streaming function, which provides the speech signal to both ears<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech reception threshold (SRT) assessment with audiological measures | differences in speech reception threshold (SRT) on the phone in the presence of background noise between the Phonak DECT phone and a standard phone will be assessed with audiological measures. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ratings assessment with scaling | differences in preference ratings in the presence of background noise between a standard phone, a standard phone + DuoPhone algorithm, the DECT-telephone differences in preference ratings in the presence of background noise between a standard mobile phone, a standard mobile phone + DuoPhone algorithm and a standard mobile phone + EasyCall accessory | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Aid Usage (monaural, binaural), Cochlear Implant Usage (monaural, binaural), Hearing Aid and Cochlear Implant Usage (monaural)