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临床试验/NCT03036410
NCT03036410已完成不适用

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

Advanced Bionics AG1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
speech reception threshold (SRT) assessment with audiological measures

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

unilateral hearing aid users

Other

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

干预措施: standard telephone setting (Device)

bimodal user

Other

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

干预措施: DuoPhone (Device)

bimodal user

Other

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

干预措施: standard telephone setting (Device)

bimodal user

Other

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

干预措施: DECT (Device)

bimodal user

Other

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

干预措施: EasyCall (Device)

unilateral hearing aid users

Other

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

干预措施: DECT (Device)

unilateral hearing aid users

Other

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

干预措施: EasyCall (Device)

bilateral hearing aid users

Other

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

干预措施: standard telephone setting (Device)

bilateral hearing aid users

Other

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

干预措施: DECT (Device)

bilateral hearing aid users

Other

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

干预措施: EasyCall (Device)

bilateral hearing aid users

Other

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

干预措施: DuoPhone (Device)

CI users

Other

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

干预措施: standard telephone setting (Device)

CI users

Other

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

干预措施: DECT (Device)

CI users

Other

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

干预措施: EasyCall (Device)

CI users

Other

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

干预措施: DuoPhone (Device)

结局指标

主要结局

speech reception threshold (SRT) assessment with audiological measures

时间窗: 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.

次要结局

  • Subjective ratings assessment with scaling(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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