Hearing LossNCT02303210
Evaluation of Frequency Lowering Technique
A study testing hearing aid NaidaUP and hearing aid NaidaSP in people with Hearing Loss, run by Phonak AG, Switzerland at 1 site in Germany.
Trial summary
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- hearing aid NaidaUP and hearing aid NaidaSP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male adults (>18 years old)
- mild to severe Hearing Loss
- symmetric Hearing Loss
- german native speakers
Who cannot join
- persons who are not able to attend multiple appointments
- persons who are not able to handle a hearing aid
- persons with a mental handicap
- persons with limited access to multiple hearing situations
- persons with psychological disease
- no acclimatization to hearing aids
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.
Read the detailed description
This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.
- Conditions
- Hearing Loss
- Being tested
- hearing aid NaidaUP, hearing aid NaidaSP
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aid NaidaUPDevice
Standard Power Hearing instruments including different frequency lowering techniques
hearing aid NaidaSPDevice
Standard Power Hearing instruments including different frequency lowering techniques
| Study group | Role | What they receive |
|---|---|---|
| hearing aid NaidaUP | Other | Within subject design: compare frequency lowering one with frequency lowering two. Receives: Device: hearing aid NaidaUP |
| hearing aid NaidaSP | Other | Within subject design: compare frequency lowering one with frequency lowering two. Receives: Device: hearing aid NaidaSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.
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 posted27 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phonak AG, Switzerland
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Rehmann, B.Sc., Study chair, Phonak AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303210
- Sponsor's protocol ID
- 012FrL2612901
- Status last verified
- Sep 2017
- First submitted
- 3 Nov 2014
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: National Regulations do not require to share data,
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Frequency Lowering Technique
- ClinicalTrials.gov ID
- NCT02303210
- Acronym / sponsor ID
- 012FrL2612901
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Phonak AG, SwitzerlandIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Nov 2014 (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.
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.
Detailed description
This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hearing aid NaidaUP | Other | Device: hearing aid NaidaUPWithin subject design: compare frequency lowering one with frequency lowering two. |
| hearing aid NaidaSP | Other | Device: hearing aid NaidaSPWithin subject design: compare frequency lowering one with frequency lowering two. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female and male adults (>18 years old)
- mild to severe Hearing Loss
- symmetric Hearing Loss
- german native speakers
Key exclusion criteria (6 listed)
- persons who are not able to attend multiple appointments
- persons who are not able to handle a hearing aid
- persons with a mental handicap
- persons with limited access to multiple hearing situations
- persons with psychological disease
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 |
|---|---|---|
| hearing aid NaidaUPStandard Power Hearing instruments including different frequency lowering techniques | Device | hearing aid NaidaUP |
| hearing aid NaidaSPStandard Power Hearing instruments including different frequency lowering techniques | Device | hearing aid NaidaSP |
Primary outcome
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.
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 25 Sep 2017.
- Individual participant dataSharing planned: No. National Regulations do not require to share data,
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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.
Julia Rehmann, B.Sc. study chair
Phonak AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hearing aid NaidaUP and hearing aid NaidaSP in people with Hearing Loss, run by Phonak AG, Switzerland at 1 site in Germany.
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 4 inclusion and 6 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 25 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 Germany. 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?
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017.