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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Binaural; Hearing Loss, Monaural
• Intervention / Treatment: Device: standard telephone setting; Device: DECT; Device: EasyCall; Device: DuoPhone

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: bimodal user; wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone	Device: standard telephone setting; without streaming function; Device: DECT; cordless telephone (streaming to both hearing devices); Device: EasyCall; accessories for Bluetooth capable mobile telephones (streaming to both hearing devices); Device: DuoPhone; streaming function, which provides the speech signal to both ears
Other: unilateral hearing aid users; wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone	Device: standard telephone setting; without streaming function; Device: DECT; cordless telephone (streaming to both hearing devices); Device: EasyCall; accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)
Other: bilateral hearing aid users; wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone	Device: standard telephone setting; without streaming function; Device: DECT; cordless telephone (streaming to both hearing devices); Device: EasyCall; accessories for Bluetooth capable mobile telephones (streaming to both hearing devices); Device: DuoPhone; streaming function, which provides the speech signal to both ears
Other: CI users; wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone	Device: standard telephone setting; without streaming function; Device: DECT; cordless telephone (streaming to both hearing devices); Device: EasyCall; accessories for Bluetooth capable mobile telephones (streaming to both hearing devices); Device: DuoPhone; streaming function, which provides the speech signal to both ears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Advanced Bionics AG
• Collaborators: Advanced Bionics

Publications and helpful links

General Publications

• 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).
• 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].
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 21, 2017
• Study Completion (Actual): August 21, 2017

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Hearing Aid Usage (monaural, binaural); Cochlear Implant Usage (monaural, binaural); Hearing Aid and Cochlear Implant Usage (monaural)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: AK-KEK-2016-01853

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No