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

Advanced Bionics

Status: Completed

Conditions: Hearing Loss, Monaural; Hearing Loss, Binaural

Treatments: Device: DECT; Device: standard telephone setting; Device: EasyCall; Device: DuoPhone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03036410

AK-KEK-2016-01853

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

bimodal user

Other group

Description:

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

Treatment:

Device: DuoPhone

Device: standard telephone setting

Device: EasyCall

Device: DECT

unilateral hearing aid users

Other group

Description:

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

Treatment:

Device: standard telephone setting

Device: EasyCall

Device: DECT

bilateral hearing aid users

Other group

Description:

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

Treatment:

Device: DuoPhone

Device: standard telephone setting

Device: EasyCall

Device: DECT

CI users

Other group

Description:

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

Treatment:

Device: DuoPhone

Device: standard telephone setting

Device: EasyCall

Device: DECT