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Clinical Trials/NCT03036410
NCT03036410CompletedNot Applicable

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

Advanced Bionics AG1 site in 1 country25 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
speech reception threshold (SRT) assessment with audiological measures

Study Overview

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.

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

unilateral hearing aid users

Other

wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: standard telephone setting (Device)

bimodal user

Other

wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DuoPhone (Device)

bimodal user

Other

wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: standard telephone setting (Device)

bimodal user

Other

wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DECT (Device)

bimodal user

Other

wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: EasyCall (Device)

unilateral hearing aid users

Other

wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DECT (Device)

unilateral hearing aid users

Other

wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: EasyCall (Device)

bilateral hearing aid users

Other

wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: standard telephone setting (Device)

bilateral hearing aid users

Other

wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DECT (Device)

bilateral hearing aid users

Other

wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: EasyCall (Device)

bilateral hearing aid users

Other

wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DuoPhone (Device)

CI users

Other

wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: standard telephone setting (Device)

CI users

Other

wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DECT (Device)

CI users

Other

wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: EasyCall (Device)

CI users

Other

wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone

Intervention: DuoPhone (Device)

Outcomes

Primary Outcomes

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

  • Subjective ratings assessment with scaling(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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