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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ponto 4 sound processor | Experimental | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitting of Ponto 4 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Recovery (NFR) Questionnaire Scores. | Self-reported work-related fatigue. The NFR scale is an 11-item scale assessing the effects of fatigue caused by work (e.g., " I find it hard to relax at the end of a working day"). Possible responses are "yes" or "no". The total NFR score is the number of "yes" responses divided by the total number of items, presented as a percentage (i.e., range 0-100). The higher the score, the greater the NfR felt by the respondent. Scores with own device compared with Ponto 4 after 3months field trial are reported. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Brassington | University Hospitals Birmingham, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audiology Department, Nuffield House, University Hospitals Birmingham | Birmingham | West Midlands | B15 2TH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ponto 4 Sound Processor | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. Fitting of Ponto 4: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ponto 4 Sound Processor | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. Fitting of Ponto 4: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Four subjects had too many eye blinks in their pupillometry recordings (>15% of trials) and therefore their pupil data were unable to be analyzed. Note, ""OSN ON", "OSN OFF" are not two separate arms/groups. "OSN ON", "OSN OFF" are test conditions. | Posted | Mean | Standard Error | percentage change | 10 days |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ponto 4 Sound Processor | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. Fitting of Ponto 4: 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. |
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Oticon Medical decided to terminate the study prematurely leading to a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Affairs | Oticon Medical | 609-366-0424 | studyinfo@oticonmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2020 | Apr 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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The participants are however blinded to the Ponto 4 setting (OpenSound Navigator ON/OFF in Ponto 4) activated for each list of sentences.
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|
| 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. |
| 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). | 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". | 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) | 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 | 1 hour |
| 4 months |
| Pupil Dilation After Field Trial. | Change in pupil dilation after field trial to check for acclimatization effects. Comparison of speech recognition scores for OSN Auto and OSN OFF at start and end of field trial. | 4 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Ponto fitting side | Ponto sound processor on the right side, left side, or both (bilateral). | Number | participants |
|
| BC in situ | Bone Conduction in situ - Pure tone average across .5, 1,2, & 3 kHz | BC in situ measures were not able to be obtained in 2 devices on the right ear and 3 on the left. | Mean | Standard Deviation | decibels |
|
| PTA BC | Bone Conduction - Pure Tone average across .5, 1, 2, & 3kHz | Mean | Standard Deviation | decibels |
|
| PTA AC | Air Conduction - Pure Tone average across .5, 1, 2, & 3 kHz | Mean | Standard Deviation | decibels |
|
| Title |
|---|
| Description |
|---|
| OG000 | Ponto 4 Sound Processor | All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally. Fitting of Ponto 4: 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. |
|
|
| Secondary | 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. | Four subjects had too many eye blinks in their pupillometry recordings (>15% of trials) and therefore their pupil data were unable to be analyzed. | Posted | Mean | Standard Deviation | Arbitrary units | 10 days |
|
|
|
| Secondary | 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. | Note that one subject did not perform the measurement at 0 dB SNR for OSN ON. Hence, the mean and std for OSN ON at 0 dB SNR is calculated for N=13, while all the other conditions are averaged across all subjects (N=14). | Posted | Mean | Standard Deviation | Percentage correct | 10 days |
|
|
|
| Secondary | 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). | Two subjects did not complete the SSQ at the 1 month timepoint. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | 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". | One subject did not complete the preference questionnaire. | Posted | Number | participants | 4 months |
|
|
|
| Secondary | 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) | A threshold was unable to be obtained for two subjects' right ears and three left ears. | Posted | Mean | Standard Deviation | decibels | 4 months |
|
|
|
| Secondary | 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 | A threshold was unable to be obtained for two subjects' right ears and three left. | Posted | Mean | Standard Deviation | decibels | 1 hour |
|
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| Other Pre-specified | Need for Recovery (NFR) Questionnaire Scores. | Self-reported work-related fatigue. The NFR scale is an 11-item scale assessing the effects of fatigue caused by work (e.g., " I find it hard to relax at the end of a working day"). Possible responses are "yes" or "no". The total NFR score is the number of "yes" responses divided by the total number of items, presented as a percentage (i.e., range 0-100). The higher the score, the greater the NfR felt by the respondent. Scores with own device compared with Ponto 4 after 3months field trial are reported. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
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| Other Pre-specified | Pupil Dilation After Field Trial. | Change in pupil dilation after field trial to check for acclimatization effects. Comparison of speech recognition scores for OSN Auto and OSN OFF at start and end of field trial. | Posted | Mean | Standard Deviation | percent correct speech scores | 4 months |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OSN ON 0dB SNR |
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| OSN ON +4dB SNR |
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| OSN ON +8dB SNR |
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| OSN OFF -8dB SNR |
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| OSN OFF -4dB SNR |
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| OSN OFF 0dB SNR |
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| OSN OFF +4dB SNR |
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| OSN OFF +8dB SNR |
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| Before Trial - Qualities |
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| Before Trial - Total |
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| 1 month - Speech |
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| 1 month - Spatial |
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| 1 month - Qualities |
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| 1 month - Total |
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| 3 months - Speech |
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| 3 months - Spatial |
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| 3 months - Qualities |
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| 3 months - Total |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
| OSN OFF at end |
|