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

Conductive Hearing Loss Clinical Trial

Official title:

Evaluation of a Sound Processor for a Transcutaneous System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05628285
• Other study ID #: BC114
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: January 2024
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Mixed Hearing Loss

Intervention

Device:
• Sentio 1
Sound processor

Locations

Country	Name	City	State
Sweden	Habilitation & Health, Hearing organization	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Secondary	To assess the improvement of hearing with the Sentio1	Functional gain with Sentio 1, i.e., the difference in dB between unaided and aided sound field thresholds, for all measured frequencies.	1 month
Secondary	Subjective evaluation of sound processor performance. 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.	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.	1 month
Secondary	Subjective sound processor preference	Percentage (%) of subjects who prefer the Sentio 1 over current sound processor	1 month
Secondary	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
Secondary	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	1 month
Secondary	Assess safety with the Sentio 1 sound processor	Tabulation of AEs occurred throughout the investigation and percentage of individuals with reported AEs.	12 months