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

Evaluation of a Sound Processor for a Transcutaneous System

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.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Mixed Hearing Loss
• Intervention / Treatment: Device: Sentio 1

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41663
    • Habilitation & Health, Hearing organization

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Signed Informed Consent Form
2. Adult subjects (18 years or older)
3. Subjects implanted with an I1 implant
4. Fluent in Swedish

Exclusion Criteria:

1. 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.
2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Sentio 1 sound processor; The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.	Device: Sentio 1; Sound processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the Improvement of Hearing With the Sentio1 (PTA4)	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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the Improvement of Hearing With the Sentio1	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.	1 month
Subjective Evaluation of Sound Processor Performance.	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	1 month
Subjective Sound Processor Preference	Percentage (%) of subjects who prefer the Sentio 1 over current sound processor	1 month
To Assess the Degree to Which Sentio 1 Compensates for the BC Hearing Loss	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).	1 month
To Assess the Difference Between BC In-situ Thresholds Measured With Sentio 1 and Conventional Unmasked BC Audiometry.	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.	1 month
Assess Safety With the Sentio 1 Sound Processor	Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.	12 months

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Ann-Charlotte Persson, Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: BC114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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