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

Primary Purpose

Bilateral Hearing Loss

Status

Terminated

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Fitting of Ponto 4

About this trial

This is an interventional basic science trial for Bilateral Hearing Loss focused on measuring Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Audiology Department, Nuffield House, University Hospitals Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ponto 4 sound processor

Arm Description

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

Outcomes

Primary Outcome Measures

Overall pupil dilation

Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR

Secondary Outcome Measures

Peak and overall pupil dilation

Pupil dilation at different SNRs

Growth Curve Analysis parameters.

GCA at different SNRs

Speech recognition scores

Performance (% correct) at different SNRs

Speech Spatial and Qualities of Hearing scale (SSQ) questionnaire scores

Self-reported perception before, during, and after field trial. The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect".

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 much better".

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.

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.

Full Information

NCT ID

NCT04242940

First Posted

January 22, 2020

Last Updated

September 26, 2022

Sponsor

Oticon Medical

1. Study Identification

Unique Protocol Identification Number

NCT04242940

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Terminated

Why 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.

Study Start Date

February 21, 2020 (Actual)

Primary Completion Date

May 17, 2022 (Actual)

Study Completion Date

May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Hearing Loss

Keywords

Bone anchored hearing systems, BAHS, Listening effort, Pupillometry, Ponto 4

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

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.

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ponto 4 sound processor

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Fitting of Ponto 4

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall pupil dilation

Description

Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR

Time Frame

10 days

Secondary Outcome Measure Information:

Title

Peak and overall pupil dilation

Description

Pupil dilation at different SNRs

Time Frame

10 days

Title

Growth Curve Analysis parameters.

Description

GCA at different SNRs

Time Frame

10 days

Title

Speech recognition scores

Description

Performance (% correct) at different SNRs

Time Frame

10 days

Title

Speech Spatial and Qualities of Hearing scale (SSQ) questionnaire scores

Description

Self-reported perception before, during, and after field trial. The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect".

Time Frame

4 months

Title

Preference questionnaire scores.

Description

Time Frame

4 months

Title

Aided sound field thresholds

Description

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.

Time Frame

4 months

Title

BC in situ thresholds.

Description

Time Frame

1 hour

Other Pre-specified Outcome Measures:

Title

Need for Recovery (NFR) questionnaire scores.

Description

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.

Time Frame

4 months

Title

Pupil dilation after field trial.

Description

Change in pupil dilation after field trial to check for acclimatization effects.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Brassington

Organizational Affiliation

University Hospitals Birmingham, United Kingdom

Official's Role

Principal Investigator

Facility Information:

Facility Name

Audiology Department, Nuffield House, University Hospitals Birmingham

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

12. IPD Sharing Statement

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

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