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

Oticon Medical11 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Conductive Hearing Loss Mixed Hearing Loss

Interventions

Sentio 1DEVICE

Sound processor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Habilitation & Health, Hearing organization

Gothenburg, Sweden

Outcomes

Primary Outcomes

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).

Time frame: 1 month

Secondary Outcomes

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.

Time frame: 1 month

Subjective Evaluation of Sound Processor Performance.

Sentio 1 compared to previous sound processor. 1. Average SSQ12 scores with Sentio 1 for each question, sub-scales and in total. 2. Average SSQ12 scores with current sound processor for each question, sub-scales and in total. 3. 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

Time frame: 1 month

Subjective Sound Processor Preference

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

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

Time frame: 1 month