Hearing LossNCT05284903
Hearing Aid Performance Study for Different Spatial Configurations
A study testing Beamformer Benefit: Speech intelligibility and Listening effort, Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility and Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition) in people with Hearing Loss, run by Sonova AG at 1 site in Germany.
Trial summary
This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users. 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?
- Beamformer Benefit: Speech intelligibility and Listening effort, Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility and Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 21 Mar 2022to 5 Jul 2022
- 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
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Written and spoken German,
- Ability to understand instruction,
- Ability to describe listening experiences,
- Ability to attend to the appointments,
Show all 9Show fewer
- Healthy outer ear,
- Hearing loss within the fitting ranges of the investigational product,
- Informed consent as documented by signature.
Who cannot join
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users.
Read the detailed description
Hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. The main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. Evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. However, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources.
This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:
- Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
- Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
- Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user
- Conditions
- Hearing Loss
- Being tested
- Beamformer Benefit: Speech intelligibility and Listening effort, Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility, Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition), Hearing aid benefit: Speech intelligibility in noise (aided condition)
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beamformer Benefit: Speech intelligibility and Listening effortOther
Confirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front.
Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibilityOther
Confirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room.
Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment.
Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)Other
Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition.
Hearing aid benefit: Speech intelligibility in noise (aided condition)Other
Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Phonak device with activated feature | Other | The clinical investigation is designed to evaluate clinical performances in terms of speech intelligibility and listening effort. The expected benefit is based on clinical relevant differences. This clinical investigation is divided in three parts including Beamformer benefit, Speech Enhancer benefit and Hearing aid benefit (this part will be performed aided). Receives: Other: Beamformer Benefit: Speech intelligibility and Listening effort; Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility; Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition); Other: Hearing aid benefit: Speech intelligibility in noise (aided condition) |
| Comparator: Phonak device with deactivated feature | Other | The comparative testings should be used as reference. The measures will be performed by the same participant group and the same three parts will be evaluated including Beamformer (BF) benefit, Speech Enhancer benefit and Hearing aid benefit. The reference will be performed without these features or with different settings of these features. In case of the Hearing aid benefit, the reference is an unaided fitting. Receives: Other: Beamformer Benefit: Speech intelligibility and Listening effort; Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility; Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition); Other: Hearing aid benefit: Speech intelligibility in noise (aided condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech reception threshold (SRT) for Beamformer Benefit (Oldenburg Sentence Test)
The measure of the speech reception threshold (SRT) is a procedure to evaluate the speech intelligibility in different listening conditions. The SRT in noise is defined as the signal-to-noise ratio (SNR) needed to understand 50% of the presented sentences. The SNR is adapted based on the intelligibility score of the previous sentence. The SRT will be measured with the Oldenburg Sentence Test (OLSA), which is a standard speech intelligibility test in German. The OLSA test uses nonsense sentences with equivalent difficulty.
Measured: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Secondary outcomes (5)
Listening Effort for Beamformer Benefit (ACALES)
The ACALES will be used to determine listening effort in different situations. Speech stimuli (OLSA sentences) are either presented at different levels in a background noise with fixed level or at different distances from the listener in a quiet environment. This creates different SNRs (speech levels at the position of the listener). The listening effort is subjectively rated on a predefined 13-point categorical scale with varying difficulties (SNRs or talker distance), 1= "no effort", 7 = "moderate effort" to 13 = "extreme effort". ACALES adaptively chooses the SNRs or talker distances for each presentation on the basis of previous ratings.
Measured: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Listening effort for SE benefit (ACALES)
The ACALES will be used to determine listening effort in different situations. The ACALES will be repeated for 3 distances and 2 conditions (SE Off vs On). The outcome is a rating on a 13 points scale, as the difficulty is fixed by the distance now.
Measured: At the test appointment, maximum duration of the test is 120 minutes
Speech Intelligibility for SE benefit (Oldenburg Sentence Test)
The measure of the speech perception in % is an alternative procedure to evaluate the speech intelligibility in different listening conditions. The Speech perception is defined as % correct words out of a sentence list of 20 sentences. Initially an individual presentation level is measured using adaptive procedure to determine the level necessary to understand 50% of all presented words. Afterwards the correct word score can be obtained using this individual presentation level (reduced by 1 dB) by calculating the ratio of correct words by the number of total words.
Measured: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Subjective Perception, Subjective Assessment for SE benefit (Questionnaire)
A subjective assessment will be used to determine the subjective perception. For this purpose, a novel is either read by the tester aloud (with soft voice) or presented by a loudspeaker in a reverberant room in three different distances (2m, 4m, 8m) and in an adjacent room with door left ajar.
The subject rates his/her perception of the presented real and recorded speech using a questionnaire on the dimensions "loudness, listening effort and speech intelligibility". The subjects will rate the perception on the same scale (1- 100%) for both tested conditions (SE Off and SE On) with pencils with different colors to get either absolute and relative ratings.
Measured: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Speech reception threshold (SRT) for Hearing Aid Benefit (Oldenburg Sentence Test)
The measure of the speech reception threshold (SRT) is a procedure to evaluate the speech intelligibility in different listening conditions. The SRT will be measured with the Oldenburg Sentence Test (OLSA), which is a standard speech intelligibility test in German. SRTs are measured in 3 conditions: unaided, aided with fixed directional and aided with stereo zoom.
Measured: At the test appointment, maximum duration of the test is 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start21 Mar 2022
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284903
- Sponsor's protocol ID
- SRF-386
- Status last verified
- Sep 2023
- First submitted
- 10 Mar 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Aid Performance Study for Different Spatial Configurations
- ClinicalTrials.gov ID
- NCT05284903
- Acronym / sponsor ID
- SRF-386
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 17 Mar 2022 (actual)
- 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.
This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users.
Detailed description
Hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. The main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. Evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. However, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources.
This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:
- Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
- Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
- Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Phonak device with activated feature | Other | Other: Beamformer Benefit: Speech intelligibility and Listening effort, Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility, Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition), Other: Hearing aid benefit: Speech intelligibility in noise (aided condition)The clinical investigation is designed to evaluate clinical performances in terms of speech intelligibility and listening effort. The expected benefit is based on clinical relevant differences. This clinical investigation is divided in three parts including Beamformer benefit, Speech Enhancer benefit and Hearing aid benefit (this part will be performed aided). |
| Comparator: Phonak device with deactivated feature | Other | Other: Beamformer Benefit: Speech intelligibility and Listening effort, Other: Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility, Other: Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition), Other: Hearing aid benefit: Speech intelligibility in noise (aided condition)The comparative testings should be used as reference. The measures will be performed by the same participant group and the same three parts will be evaluated including Beamformer (BF) benefit, Speech Enhancer benefit and Hearing aid benefit. The reference will be performed without these features or with different settings of these features. In case of the Hearing aid benefit, the reference is an unaided fitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Written and spoken German,
- Ability to understand instruction,
- Ability to describe listening experiences,
Key exclusion criteria (4 listed)
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results.
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 |
|---|---|---|
| Beamformer Benefit: Speech intelligibility and Listening effortConfirm the improvement in terms of speech intelligibility (measured by OLSA, Oldenburg Sentence Test) and the reduction in terms of listening effort (measured by ACALES) of the I-BF (investigational Beamformer) compared to the R-BF (reference Beamformer), when speech is not coming from the front. | Other | Comparator: Phonak device with deactivated feature, Experimental: Phonak device with activated feature |
| Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibilityConfirm the improvement in terms of speech intelligibility (measured by Oldenburg Sentence test) and the reduction in terms of listening effort (measured by ACALES) when the Speech Enhancer is on (SE ON) compared to Speech Enhancer is off (SE OFF) for distant speech or speech from adjacent room. Confirm the improvement in terms of subjective level to follow a conversation in quiet when SE ON compared to SE OFF for distant speech or speech from adjacent room. Measured by a subjective assessment. | Other | Comparator: Phonak device with deactivated feature, Experimental: Phonak device with activated feature |
| Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition)Confirm the improvement in terms of speech intelligibility (measured by OLSA) in noise with the investigational device (aided condition) compared to the unaided condition. | Other | Comparator: Phonak device with deactivated feature, Experimental: Phonak device with activated feature |
| Hearing aid benefit: Speech intelligibility in noise (aided condition)Confirm the improvement in terms of speech intelligibility (measured by OLSA) with the Reference binaural beamformer compared to the fixed directional. | Other | Comparator: Phonak device with deactivated feature, Experimental: Phonak device with activated feature |
Primary outcome
Speech reception threshold (SRT) for Beamformer Benefit (Oldenburg Sentence Test)
Time frame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
The measure of the speech reception threshold (SRT) is a procedure to evaluate the speech intelligibility in different listening conditions. The SRT in noise is defined as the signal-to-noise ratio (SNR) needed to understand 50% of the presented sentences. The SNR is adapted based on the intelligibility score of the previous sentence. The SRT will be measured with the Oldenburg Sentence Test (OLSA), which is a standard speech intelligibility test in German. The OLSA test uses nonsense sentences with equivalent difficulty.
5 secondary outcomes
Listening Effort for Beamformer Benefit (ACALES)
Time frame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Listening effort for SE benefit (ACALES)
Time frame: At the test appointment, maximum duration of the test is 120 minutes
Speech Intelligibility for SE benefit (Oldenburg Sentence Test)
Time frame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Subjective Perception, Subjective Assessment for SE benefit (Questionnaire)
Time frame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes
Speech reception threshold (SRT) for Hearing Aid Benefit (Oldenburg Sentence Test)
Time frame: At the test appointment, maximum duration of the test is 120 minutes
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 6 Sep 2023.
- New implementation of directional beamforming configurations shows improved speech understanding and reduced listening effortLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Beamformer Benefit: Speech intelligibility and Listening effort, Speech Enhancer benefit: Speech intelligibility, Listening effort and Subjective Speech intelligibility and Hearing aid benefit: Speech intelligibility in noise (unaided vs aided condition) in people with Hearing Loss, run by Sonova AG 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 9 inclusion and 4 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 6 Sep 2023. 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?
Speech reception threshold (SRT) for Beamformer Benefit (Oldenburg Sentence Test) (time frame: At the test and retest appointment, maximum duration of the test/retest is 120 minutes). 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 6 Sep 2023.