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

Primary Purpose

Hearing Loss, Binaural, Hearing Loss, Monaural

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

standard telephone setting

DECT

EasyCall

DuoPhone

About this trial

This is an interventional other trial for Hearing Loss, Binaural focused on measuring Hearing Aid Usage (monaural, binaural), Cochlear Implant Usage (monaural, binaural), Hearing Aid and Cochlear Implant Usage (monaural)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

bimodal user

unilateral hearing aid users

bilateral hearing aid users

CI users

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

speech reception threshold (SRT) assessment with audiological measures

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 Outcome Measures

Subjective ratings assessment with scaling

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

Full Information

NCT ID

NCT03036410

First Posted

January 16, 2017

Last Updated

September 5, 2017

Sponsor

Advanced Bionics AG

Collaborators

Advanced Bionics

1. Study Identification

Unique Protocol Identification Number

NCT03036410

Brief Title

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

Acronym

PhoneCIHA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

August 21, 2017 (Actual)

Study Completion Date

August 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advanced Bionics AG

Collaborators

Advanced Bionics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Binaural, Hearing Loss, Monaural

Keywords

Hearing Aid Usage (monaural, binaural), Cochlear Implant Usage (monaural, binaural), Hearing Aid and Cochlear Implant Usage (monaural)

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bimodal user

Arm Type

Other

Arm Description

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

Arm Title

unilateral hearing aid users

Arm Type

Other

Arm Description

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

Arm Title

bilateral hearing aid users

Arm Type

Other

Arm Description

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

Arm Title

CI users

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

standard telephone setting

Intervention Description

without streaming function

Intervention Type

Device

Intervention Name(s)

DECT

Intervention Description

cordless telephone (streaming to both hearing devices)

Intervention Type

Device

Intervention Name(s)

EasyCall

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

DuoPhone

Intervention Description

streaming function, which provides the speech signal to both ears

Primary Outcome Measure Information:

Title

speech reception threshold (SRT) assessment with audiological measures

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Subjective ratings assessment with scaling

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Zurich

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

15903146

Citation

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).

Results Reference

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PubMed Identifier

17005487

Citation

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. Erratum In: Int J Audiol. 2006 Oct;45(10):617. Arnolder, Christoph [corrected to Arnoldner, Christoph].

Results Reference

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PubMed Identifier

15008443

Citation

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.

Results Reference

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PubMed Identifier

20808225

Citation

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.

Results Reference

background

PubMed Identifier

23231817

Citation

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.

Results Reference

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

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