Hearing Loss, Binaural Clinical Trial
— PhoneCIHAOfficial title:
Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
| Verified date | August 2017 |
| Source | Advanced Bionics AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | August 21, 2017 |
| Est. primary completion date | August 21, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Advanced Bionics AG | Advanced Bionics |
Switzerland,
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. — View Citation
Anderson I, Baumgartner WD, Böheim 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. Erratum in: Int J Audiol. 2006 Oct;45(10):617. Arnolder, Christoph [corrected to Arnoldner, Christoph]. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
6 months |