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

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ClinicalTrials.gov Identifier: NCT03036410
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Advanced Bionics
Information provided by (Responsible Party):
Advanced Bionics AG

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hearing Loss, Binaural Hearing Loss, Monaural Device: standard telephone setting Device: DECT Device: EasyCall Device: DuoPhone Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 21, 2017
Actual Study Completion Date : August 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
bimodal user
wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
Device: standard telephone setting
without streaming function

Device: DECT
cordless telephone (streaming to both hearing devices)

Device: EasyCall
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)

Device: DuoPhone
streaming function, which provides the speech signal to both ears

unilateral hearing aid users
wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
Device: standard telephone setting
without streaming function

Device: DECT
cordless telephone (streaming to both hearing devices)

Device: EasyCall
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)

bilateral hearing aid users
wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
Device: standard telephone setting
without streaming function

Device: DECT
cordless telephone (streaming to both hearing devices)

Device: EasyCall
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)

Device: DuoPhone
streaming function, which provides the speech signal to both ears

CI users
wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
Device: standard telephone setting
without streaming function

Device: DECT
cordless telephone (streaming to both hearing devices)

Device: EasyCall
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)

Device: DuoPhone
streaming function, which provides the speech signal to both ears




Primary Outcome Measures :
  1. speech reception threshold (SRT) assessment with audiological measures [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Subjective ratings assessment with scaling [ Time Frame: 6 months ]
    • 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036410


Locations
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Switzerland
University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery
Zurich, Switzerland
Sponsors and Collaborators
Advanced Bionics AG
Advanced Bionics

Publications:
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Responsible Party: Advanced Bionics AG
ClinicalTrials.gov Identifier: NCT03036410     History of Changes
Other Study ID Numbers: AK-KEK-2016-01853
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Advanced Bionics AG:
Hearing Aid Usage (monaural, binaural)
Cochlear Implant Usage (monaural, binaural)
Hearing Aid and Cochlear Implant Usage (monaural)

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms