Bilateral Hearing LossNCT04242940
Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users
A study testing Fitting of Ponto 4 in people with Bilateral Hearing Loss, run by Oticon Medical at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bilateral Hearing Loss
- What is being tested?
- Fitting of Ponto 4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2020to 17 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum 18 years and maximum 70 years old.
- UK English mother tongue.
- Bilateral conductive or mixed hearing loss.
- Users fitted unilaterally or bilaterally on abutment.
- Users are currently fitted with either Ponto 3, Ponto Plus or Ponto Pro (devices with a fitting range up to 45 dB HL).
- Users with at least 6 months of daily experience with one Ponto sound processor.
Show all 10Show fewer
- BC thresholds of the implanted ear(s) better (lower) than or equal to 40 dB HL (average of 0.5, 1, 2 and 3 kHz) based on BC in-situ measurement at the first visit.
- People currently employed/self-employed (since the Need for Recovery questionnaire refers to work-related fatigue).
- Speech recognition scores better (higher) than or equal to 50% at +4 dB SNR with OSN OFF (as assessed via the first training list at Visit 1). This is to avoid including patients that are already "giving up" at +4 dB SNR.
- Users entitled for a sound-processor upgrade (according to the investigator) will first be selected. If there are not enough users entitled for an upgrade, then patients fitted with Ponto between 7 and 12 months before visit 1 will be considered. If there are not enough users within 7-12 months, then patients fitted with Ponto between 13 and 18 months before visit 1 will be considered.
Who cannot join
- Single-sided deafness (SSD)
- Hearing aid or cochlear implant on the opposite ear.
- Test persons with current eye diseases and/or history of eye surgery on both eyes.
- If the patient takes medications that can impact the autonomic nervous system - and hence pupil dilation (e.g., drugs for Parkinson's disease, peptic ulcers, incontinence, motion sickness).
- If the investigator or physician assesses that the patient is not fit for trial participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Audiology Department, Nuffield House, University Hospitals Birmingham
Birmingham, West Midlands, B15 2TH
About this study
The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.
Read the detailed description
Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings (OpenSound Navigator ON and OFF) of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty (i.e., in terms of signal-to-noise ratio, SNR). Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient's own device). All these outcome measures are non-invasive measurements. This is a post market study and all products used are CE marked and used in clinical practice worldwide.
- Conditions
- Bilateral Hearing Loss
- Being tested
- Fitting of Ponto 4
- Keywords
- Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitting of Ponto 4Device
Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments.
| Study group | Role | What they receive |
|---|---|---|
| Ponto 4 sound processor | Experimental | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. Receives: Device: Fitting of Ponto 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pupil Dilation
Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR
a third-order polynomial function was fit to the pupil dilation data, with the OSN setting as a fixed factor, as well as the interaction of OSN with each of the polynomial time terms. The formula used is the following: Pupil Dilation = (Linear + Quadratic + Cubic) X OSN setting + (1 + Linear + Quadratic + Cubic| Subject); where the Linear, Quadratic, and Cubic are the orthogonal terms; X indicates the interaction with OSN setting, and the terms reported in the second parenthesis are the random factors. The random factors include the effect of listeners, and of each of the time terms, to account for the variability in the time course of dilation across listeners.
Outcome measure is the percentage reduction(% change) in pupil dilation with OSN ON vs OSN OFF
Measured: 10 days
Secondary outcomes (6)
Peak Pupil Dilation (PPD) for OSN ON and OSN OFF
The difference in pupil dilation between OSN ON and OSN OFF was also analyzed via Peak Pupil Dilation (PPD); thus, by investigating differences in dilation at the peak of the curve. The PPD was obtained for each subject as the maximum dilation between 7.5 and 9 s.
Measured: 10 days
Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs
A mixed-linear model with OSN setting (2 levels: ON and OFF) and SNR (5 levels: -8, -4, 0, +4, +8 dB) as fixed factors, and subject as random factor, was fit to the data.
Measured: 10 days
Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores
Self-reported perception before, during (at 1 month), and after field trial (at 3months).
The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect".
The SSQ questionnaire is comprised of three subscales domains (Speech, Spatial, and Qualities of Hearing) - that is, each of the 49 items fits into one of these subscale "categories".
The subscale scores AND the total scores (the total score is comprised of all of the 49 items) use the same scale of 0 to 10 where 0 represents "Not at all" and 10 represents "Perfect". For the total scale and all subscales (again all questions and by extension, the scales range from 0 to 10) the higher the value (closer to 10) represents a better outcome than lower values (closer to 0).
Measured: 4 months
Preference Questionnaire Scores.
Self-reported preference after field trial. The preference questionnaire consists of 11 questions. The scores are from 1 to 5, where 1 means "Own sound processor much better" and 5 means "Test sound processor [Ponto 4] much better".
Measured: 4 months
Aided Sound Field Thresholds
Sound field audiometry performed with the Auricle system while the patient is wearing the Ponto sound processor. This measurement is conducted at 10 frequencies from 250 Hz to 8 kHz. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz)
Measured: 4 months
BC in Situ Thresholds.
Hearing level thresholds (dB HL) as assessed in situ with Ponto 4 placed on the patient's abutment. Bone-conduction thresholds (BC) are measured as the softest sound level that is audible by the patient at 10 frequencies from 250 Hz to 8 kHz. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start21 Feb 2020
- Primary completion17 May 2022
- Study completion17 May 2022
Why it stopped: The sponsor decided to terminate the study prematurely given that patient enrollment was delayed by more than two years relative to what originally stated in the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bilateral 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Brassington, Principal investigator, University Hospitals Birmingham, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242940
- Sponsor's protocol ID
- BC103
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2020
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users
- ClinicalTrials.gov ID
- NCT04242940
- Acronym / sponsor ID
- BC103
- Conditions
- Bilateral Hearing Loss
- Keywords
- Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study prematurely given that patient enrollment was delayed by more than two years relative to what originally stated in the protocol.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 15 May 2025
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 assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.
Detailed description
Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings (OpenSound Navigator ON and OFF) of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty (i.e., in terms of signal-to-noise ratio, SNR). Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient's own device). All these outcome measures are non-invasive measurements. This is a post market study and all products used are CE marked and used in clinical practice worldwide.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ponto 4 sound processor | Experimental | Device: Fitting of Ponto 4All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum 18 years and maximum 70 years old.
- UK English mother tongue.
- Bilateral conductive or mixed hearing loss.
- Users fitted unilaterally or bilaterally on abutment.
- Users are currently fitted with either Ponto 3, Ponto Plus or Ponto Pro (devices with a fitting range up to 45 dB HL).
Key exclusion criteria (5 listed)
- Single-sided deafness (SSD)
- Hearing aid or cochlear implant on the opposite ear.
- Test persons with current eye diseases and/or history of eye surgery on both eyes.
- If the patient takes medications that can impact the autonomic nervous system - and hence pupil dilation (e.g., drugs for Parkinson's disease, peptic ulcers, incontinence, motion sickness).
- If the investigator or physician assesses that the patient is not fit for trial participation.
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 |
|---|---|---|
| Fitting of Ponto 4Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments. | Device | Ponto 4 sound processor |
Primary outcome
Overall Pupil Dilation
Time frame: 10 days
Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR a third-order polynomial function was fit to the pupil dilation data, with the OSN setting as a fixed factor, as well as the interaction of OSN with each of the polynomial time terms. The formula used is the following: Pupil Dilation = (Linear + Quadratic + Cubic) X OSN setting + (1 + Linear + Quadratic + Cubic| Subject); where the Linear, Quadratic, and Cubic are the orthogonal terms; X indicates the interaction with OSN setting, and the terms reported in the second parenthesis are the random factors. The random factors include the effect of listeners, and of each of the time terms, to account for the variability in the time course of dilation across listeners. Outcome measure is the percentage reduction(% change) in pupil dilation with OSN ON vs OSN OFF
6 secondary outcomes
Peak Pupil Dilation (PPD) for OSN ON and OSN OFF
Time frame: 10 days
Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs
Time frame: 10 days
Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores
Time frame: 4 months
Preference Questionnaire Scores.
Time frame: 4 months
Aided Sound Field Thresholds
Time frame: 4 months
BC in Situ Thresholds.
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William Brassington principal investigator
University Hospitals Birmingham, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitting of Ponto 4 in people with Bilateral Hearing Loss, run by Oticon Medical at 1 site in United Kingdom.
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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 May 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Pupil Dilation (time frame: 10 days). 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 15 May 2025.