Skip to main content
OpenTrials
Completed

NCT Number: NCT05628285

Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habilitation & Health, Hearing organization

Gothenburg, 41663, Sweden

About this study

Bone conduction hearing systems 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. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent Form
  • Adult subjects (18 years or older)
  • Subjects implanted with an I1 implant
  • Fluent in Swedish

Exclusion criteria

  • Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion.
  • Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

Treatment and study plan

Sentio 1

Device

Sound processor

Primary outcomes

  1. To Assess the Improvement of Hearing With the Sentio1 (PTA4)

    Time frame: 1 month

    Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

    In detail, for each patient, sound field thresholds are measured at the frequencies 500, 1000, 2000 and 4000 Hz for which a mean value is calculated and denoted as PTA4.

    The primary outcome measure is functional gain which is the difference in PTA4 measured unaided (without sound processor) versus aided condition (with sound processor).

Secondary outcomes

  1. To Assess the Improvement of Hearing With the Sentio1

    Time frame: 1 month

    Functional gain with Sentio 1, i.e., the difference in dB between unaided (without sound processor) and aided (with sound processor on) sound field thresholds, for all measured frequencies.

    In detail, for each patient, sound field thresholds are measured at the frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz, with and without the sound processor on.

  2. Subjective Evaluation of Sound Processor Performance.

    Time frame: 1 month

    Sentio 1 compared to previous sound processor.

    • Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total.
    • Average SSQ12 scores with current sound processor for each question, sub-scales and in total.
    • Difference in SSQ12 scores between Sentio 1 and current sound processor for each question, sub-scales and in total.

    Measured by the Speech, Spatial and Quality (SSQ) scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". Higher scores mean a better outcome. For each of the scales the item outcomes are averaged. Fot the total score all items are averaged

  3. Subjective Sound Processor Preference

    Time frame: 1 month

    Percentage (%) of subjects who prefer the Sentio 1 over current sound processor

  4. To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss

    Time frame: 1 month

    • Effective gain defined as the difference in dB between aided sound field thresholds with Sentio 1 and unmasked BC thresholds on the aided ear(s). The effective gain is calculated for all measured frequencies.
    • Effective gain with Sentio 1, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

  5. To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.

    Time frame: 1 month

    Difference in dB between Sentio 1 BC in situ thresholds and BC thresholds measured with conventional unmasked BC audiometry for the frequencies 500, 1000, 2000, 3000 and 4000 Hz.

    The BC in-situ threshold is a measure of the inner ear functionality with the device. This should correspond to the unmasked BC thresholds measured with conventional audiometry. The difference was calculated as the threshold value measured with Sentio 1 minus the threshold value measured with conventional audiometry. Negative values indicate that the thresholds measured with Sentio 1 were lower (better) compared to those measured with conventional audiometry. Conversely, positive values indicate that the thresholds measured with Sentio 1 were higher (worse) compared to conventional audiometry. It's expected that two measurements should be comparable to each with a difference of maximum +/-5 dB.

  6. Assess Safety With the Sentio 1 Sound Processor

    Time frame: 12 months

    Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

Evaluation of a Sound Processor for a Transcutaneous System

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 28, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.