Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
PhoneCIHA
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2017
CompletedSeptember 7, 2017
August 1, 2017
7 months
January 16, 2017
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (1)
Subjective ratings assessment with scaling
6 months
Study Arms (4)
bimodal user
OTHERwearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
unilateral hearing aid users
OTHERwearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
bilateral hearing aid users
OTHERwearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
CI users
OTHERwearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone
Interventions
without streaming function
cordless telephone (streaming to both hearing devices)
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)
streaming function, which provides the speech signal to both ears
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanced Bionics AGlead
- Advanced Bionicscollaborator
Study Sites (1)
University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery
Zurich, Switzerland
Related Publications (5)
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).
PMID: 15903146BACKGROUNDAnderson 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.
PMID: 17005487BACKGROUNDAdams 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.
PMID: 15008443BACKGROUNDPicou 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.
PMID: 20808225BACKGROUNDPicou 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.
PMID: 23231817BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 30, 2017
Study Start
February 1, 2017
Primary Completion
August 21, 2017
Study Completion
August 21, 2017
Last Updated
September 7, 2017
Record last verified: 2017-08