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

NCT ID: NCT03036410

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-08-21

Brief Summary

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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

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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

Conditions

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Hearing Loss, Binaural Hearing Loss, Monaural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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bimodal user

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

Group Type OTHER

standard telephone setting

Intervention Type DEVICE

without streaming function

DECT

Intervention Type DEVICE

cordless telephone (streaming to both hearing devices)

EasyCall

Intervention Type DEVICE

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

DuoPhone

Intervention Type DEVICE

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

Group Type OTHER

standard telephone setting

Intervention Type DEVICE

without streaming function

DECT

Intervention Type DEVICE

cordless telephone (streaming to both hearing devices)

EasyCall

Intervention Type DEVICE

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

Group Type OTHER

standard telephone setting

Intervention Type DEVICE

without streaming function

DECT

Intervention Type DEVICE

cordless telephone (streaming to both hearing devices)

EasyCall

Intervention Type DEVICE

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

DuoPhone

Intervention Type DEVICE

streaming function, which provides the speech signal to both ears

CI users

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

Group Type OTHER

standard telephone setting

Intervention Type DEVICE

without streaming function

DECT

Intervention Type DEVICE

cordless telephone (streaming to both hearing devices)

EasyCall

Intervention Type DEVICE

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

DuoPhone

Intervention Type DEVICE

streaming function, which provides the speech signal to both ears

Interventions

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standard telephone setting

without streaming function

Intervention Type DEVICE

DECT

cordless telephone (streaming to both hearing devices)

Intervention Type DEVICE

EasyCall

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

Intervention Type DEVICE

DuoPhone

streaming function, which provides the speech signal to both ears

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics

INDUSTRY

Sponsor Role collaborator

Advanced Bionics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Cray JW, Allen RL, Stuart A, Hudson S, Layman E, Givens GD. An investigation of telephone use among cochlear implant recipients. Am J Audiol. 2004 Dec;13(2):200-12. doi: 10.1044/1059-0889(2004/025).

Reference Type BACKGROUND
PMID: 15903146 (View on PubMed)

Anderson I, Baumgartner WD, Boheim K, Nahler A, Arnoldner C, D'Haese P. Telephone use: what benefit do cochlear implant users receive? Int J Audiol. 2006 Aug;45(8):446-53. doi: 10.1080/14992020600690969.

Reference Type BACKGROUND
PMID: 17005487 (View on PubMed)

Adams JS, Hasenstab MS, Pippin GW, Sismanis A. Telephone use and understanding in patients with cochlear implants. Ear Nose Throat J. 2004 Feb;83(2):96, 99-100, 102-3.

Reference Type BACKGROUND
PMID: 15008443 (View on PubMed)

Picou EM, Ricketts TA. Comparison of wireless and acoustic hearing aid-based telephone listening strategies. Ear Hear. 2011 Mar-Apr;32(2):209-20. doi: 10.1097/AUD.0b013e3181f53737.

Reference Type BACKGROUND
PMID: 20808225 (View on PubMed)

Picou EM, Ricketts TA. Efficacy of hearing-aid based telephone strategies for listeners with moderate-to-severe hearing loss. J Am Acad Audiol. 2013 Jan;24(1):59-70. doi: 10.3766/jaaa.24.1.7.

Reference Type BACKGROUND
PMID: 23231817 (View on PubMed)

Other Identifiers

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AK-KEK-2016-01853

Identifier Type: -

Identifier Source: org_study_id

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