Hearing Loss, BinauralPhoneCIHANCT03036410
Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
A study testing standard telephone setting, DECT and EasyCall in people with Hearing Loss, Binaural and Hearing Loss, Monaural, run by Advanced Bionics AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hearing Loss, Binaural, Hearing Loss, Monaural
- What is being tested?
- standard telephone setting, DECT and EasyCall
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 21 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Otorhinolaryngology, Head and Neck Surgery
Zurich
About this study
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.
Read the 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
- Conditions
- Hearing Loss, Binaural, Hearing Loss, Monaural
- Being tested
- standard telephone setting, DECT, EasyCall, DuoPhone
- Keywords
- Hearing Aid Usage (monaural, binaural), Cochlear Implant Usage (monaural, binaural), Hearing Aid and Cochlear Implant Usage (monaural)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard telephone settingDevice
without streaming function
DECTDevice
cordless telephone (streaming to both hearing devices)
EasyCallDevice
accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)
DuoPhoneDevice
streaming function, which provides the speech signal to both ears
| Study group | Role | What they receive |
|---|---|---|
| bimodal user | Other | wearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone Receives: Device: standard telephone setting; Device: DECT; Device: EasyCall; Device: DuoPhone |
| unilateral hearing aid users | Other | wearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone Receives: Device: standard telephone setting; Device: DECT; Device: EasyCall |
| bilateral hearing aid users | Other | wearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone Receives: Device: standard telephone setting; Device: DECT; Device: EasyCall; Device: DuoPhone |
| CI users | Other | wearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone Receives: Device: standard telephone setting; Device: DECT; Device: EasyCall; Device: DuoPhone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion21 Aug 2017
- Study completion21 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, BinauralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Bionics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036410
- Sponsor's protocol ID
- AK-KEK-2016-01853
- Acronym
- PhoneCIHA
- Status last verified
- Aug 2017
- First submitted
- 16 Jan 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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).
PubMed 15903146Anderson 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.
PubMed 17005487Adams 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.
PubMed 15008443Picou 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.
PubMed 20808225Picou 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.
PubMed 23231817
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Phone Solutions in CI and Hearing Aid Users and Bimodal Recipients
- ClinicalTrials.gov ID
- NCT03036410
- Acronym / sponsor ID
- PhoneCIHA / AK-KEK-2016-01853
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Advanced Bionics AGIndustry (pharma, biotech, devices)
- Collaborators
- Advanced Bionics
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 21 Aug 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bimodal user | Other | Device: standard telephone setting, Device: DECT, Device: EasyCall, Device: DuoPhonewearing one hearing aid and one CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone |
| unilateral hearing aid users | Other | Device: standard telephone setting, Device: DECT, Device: EasyCallwearing one hearing aid Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone |
| bilateral hearing aid users | Other | Device: standard telephone setting, Device: DECT, Device: EasyCall, Device: DuoPhonewearing two hearing aids Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone |
| CI users | Other | Device: standard telephone setting, Device: DECT, Device: EasyCall, Device: DuoPhonewearing CI Intervention: Standard Phone, DECT Phone, Easy Call, Duo Phone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard telephone settingwithout streaming function | Device | CI users, bilateral hearing aid users, bimodal user, unilateral hearing aid users |
| DECTcordless telephone (streaming to both hearing devices) | Device | CI users, bilateral hearing aid users, bimodal user, unilateral hearing aid users |
| EasyCallaccessories for Bluetooth capable mobile telephones (streaming to both hearing devices) | Device | CI users, bilateral hearing aid users, bimodal user, unilateral hearing aid users |
| DuoPhonestreaming function, which provides the speech signal to both ears | Device | CI users, bilateral hearing aid users, bimodal user |
Primary outcome
speech reception threshold (SRT) assessment with audiological measures
Time frame: 6 months
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.
1 secondary outcome
Subjective ratings assessment with scaling
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 15903146Cray 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).
- Background: PubMed 17005487Anderson 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.
- Background: PubMed 15008443Adams 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.
- Background: PubMed 20808225Picou 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.
- Background: PubMed 23231817Picou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard telephone setting, DECT and EasyCall in people with Hearing Loss, Binaural and Hearing Loss, Monaural, run by Advanced Bionics AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
speech reception threshold (SRT) assessment with audiological measures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03036410, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.