Bilateral Hearing Loss
Conditions
Keywords
Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4
Brief 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.
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.
Interventions
DEVICEFitting 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.
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The participants are however blinded to the Ponto 4 setting (OpenSound Navigator ON/OFF in Ponto 4) activated for each list of sentences.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pupil Dilation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pupil Dilation (PPD) for OSN ON and OSN OFF | 10 days | 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. |
| Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | 10 days | 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. |
| Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 4 months | 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). |
| Aided Sound Field Thresholds | 4 months | 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) |
| BC in Situ Thresholds. | 1 hour | 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 |
| Preference Questionnaire Scores. | 4 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for Recovery (NFR) Questionnaire Scores. | 4 months | 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. |
| Pupil Dilation After Field Trial. | 4 months | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Ponto 4 Sound Processor | — |
|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 12.4 | — |
| BC in situ Left Ear | 22.61 decibels STANDARD_DEVIATION 10.61 | — |
| BC in situ Right Ear | 20.83 decibels STANDARD_DEVIATION 9.82 | — |
| Ponto fitting side Bilateral | 8 participants | — |
| Ponto fitting side Left Side | 2 participants | — |
| Ponto fitting side Right Side | 3 participants | — |
| PTA AC Left Ear | 61.96 decibels STANDARD_DEVIATION 12.25 | — |
| PTA AC Right Ear | 63.75 decibels STANDARD_DEVIATION 12.53 | — |
| PTA BC Left Ear | 26.52 decibels STANDARD_DEVIATION 9.53 | — |
| PTA BC Right Ear | 27.23 decibels STANDARD_DEVIATION 9.62 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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
Time frame: 10 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ponto 4 Sound Processor | Overall Pupil Dilation | 58.7 percentage change | Standard Error 0.3 |
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)
Time frame: 4 months
Population: A threshold was unable to be obtained for two subjects' right ears and three left ears.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Aided Sound Field Thresholds | Aided Right Ear | 32.29 decibels | Standard Deviation 9.35 |
| Ponto 4 Sound Processor | Aided Sound Field Thresholds | Aided Left Ear | 37.95 decibels | Standard Deviation 9.12 |
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
Time frame: 1 hour
Population: A threshold was unable to be obtained for two subjects' right ears and three left.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | BC in Situ Thresholds. | BC in situ Right Ear | 20.83 decibels | Standard Deviation 9.82 |
| Ponto 4 Sound Processor | BC in Situ Thresholds. | BC in situ Left Ear | 22.61 decibels | Standard Deviation 10.61 |
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.
Time frame: 10 days
Population: Four subjects had too many eye blinks in their pupillometry recordings (\>15% of trials) and therefore their pupil data were unable to be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Peak Pupil Dilation (PPD) for OSN ON and OSN OFF | PPD - OSN OFF | 1.80 Arbitrary units | Standard Deviation 1.34 |
| Ponto 4 Sound Processor | Peak Pupil Dilation (PPD) for OSN ON and OSN OFF | PPD - OSN ON | 1.05 Arbitrary units | Standard Deviation 1.56 |
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.
Time frame: 4 months
Population: One subject did not complete the preference questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ponto 4 Sound Processor | Preference Questionnaire Scores. | Prefer Ponto 4 | 11 participants |
| Ponto 4 Sound Processor | Preference Questionnaire Scores. | No preference | 2 participants |
| Ponto 4 Sound Processor | Preference Questionnaire Scores. | Prefer own device | 0 participants |
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.
Time frame: 10 days
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN ON -8dB SNR | 21.66 Percentage correct | Standard Deviation 16.24 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN ON -4dB SNR | 51.77 Percentage correct | Standard Deviation 19.63 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN ON 0dB SNR | 79.26 Percentage correct | Standard Deviation 13.96 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN ON +4dB SNR | 95.41 Percentage correct | Standard Deviation 3.33 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN ON +8dB SNR | 97.41 Percentage correct | Standard Deviation 2.49 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN OFF -8dB SNR | 5.82 Percentage correct | Standard Deviation 8.27 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN OFF -4dB SNR | 30.85 Percentage correct | Standard Deviation 25.61 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN OFF 0dB SNR | 66.51 Percentage correct | Standard Deviation 16.31 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN OFF +4dB SNR | 89.45 Percentage correct | Standard Deviation 6.38 |
| Ponto 4 Sound Processor | Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs | OSN OFF +8dB SNR | 95.78 Percentage correct | Standard Deviation 3.95 |
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).
Time frame: 4 months
Population: Two subjects did not complete the SSQ at the 1 month timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | Before Trial - Speech | 4.98 score on a scale | Standard Deviation 1.6 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | Before Trial - Spatial | 3.87 score on a scale | Standard Deviation 1.35 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | Before Trial - Qualities | 5.98 score on a scale | Standard Deviation 1.63 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | Before Trial - Total | 4.94 score on a scale | Standard Deviation 1.33 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 1 month - Speech | 5.67 score on a scale | Standard Deviation 1.46 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 1 month - Spatial | 4.87 score on a scale | Standard Deviation 1.66 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 1 month - Qualities | 6.67 score on a scale | Standard Deviation 1.13 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 1 month - Total | 5.74 score on a scale | Standard Deviation 1.34 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 3 months - Speech | 5.88 score on a scale | Standard Deviation 1.35 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 3 months - Spatial | 4.83 score on a scale | Standard Deviation 1.45 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 3 months - Qualities | 6.46 score on a scale | Standard Deviation 1.12 |
| Ponto 4 Sound Processor | Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores | 3 months - Total | 5.72 score on a scale | Standard Deviation 1.23 |
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.
Time frame: 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Need for Recovery (NFR) Questionnaire Scores. | Own device | 47.4 score on a scale | Standard Deviation 37.3 |
| Ponto 4 Sound Processor | Need for Recovery (NFR) Questionnaire Scores. | Ponto 4 (3 months) | 47.4 score on a scale | Standard Deviation 34 |
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.
Time frame: 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ponto 4 Sound Processor | Pupil Dilation After Field Trial. | OSN Auto at start | 94.7 percent correct speech scores | Standard Deviation 5.1 |
| Ponto 4 Sound Processor | Pupil Dilation After Field Trial. | OSN Auto at end | 94.4 percent correct speech scores | Standard Deviation 2.7 |
| Ponto 4 Sound Processor | Pupil Dilation After Field Trial. | OSN OFF at start | 89.5 percent correct speech scores | Standard Deviation 6.4 |
| Ponto 4 Sound Processor | Pupil Dilation After Field Trial. | OSN OFF at end | 86.9 percent correct speech scores | Standard Deviation 7.6 |