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Completed

NCT Number: NCT03036410

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

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.

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Key information

Conditions

Hearing Loss, Binaural Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Monaural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery

Zurich, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard telephone setting

Device

without streaming function

DECT

Device

cordless telephone (streaming to both hearing devices)

EasyCall

Device

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

DuoPhone

Device

streaming function, which provides the speech signal to both ears

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Advanced Bionics AG

Industry

Collaborators

  • Advanced Bionics

Registry information

Acronym: PhoneCIHA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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