Clinical trial NCT03036410: Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
Official title: Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Binaural
Hearing Loss, Monaural
Keywords: Hearing Aid Usage (monaural, binaural)
Cochlear Implant Usage (monaural, binaural)
Hearing Aid and Cochlear Implant Usage (monaural)
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
Collaborators: name: Advanced Bionics
First posted: 2017-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: speech reception threshold (SRT) assessment with audiological measures
timeFrame: 6 months
Secondary outcomes:
measure: Subjective ratings assessment with scaling
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery
Study officials:
References:
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).
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.
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.
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.
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.