Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

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.

Study Overview

• Status: Terminated
• Conditions: Bilateral Hearing Loss
• Intervention / Treatment: Device: Fitting of Ponto 4

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Audiology Department, Nuffield House, University Hospitals Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ponto 4 sound processor; All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: William Brassington, University Hospitals Birmingham, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2020
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: BAHS; Pupillometry; Listening effort; Bone anchored hearing systems; Ponto 4
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Hearing Loss, Bilateral
• Other Study ID Numbers: BC103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No