Evaluation of Sound Processor for a Transcutaneous System

NCT03374787 | Completed Results

• 1 other identifier: C58
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 speech intelligibility and self evaluation questionnaires.

Conditions

Conductive Hearing Loss; Mixed Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Aided Thresholds Fusion-unaided PTA

  Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

  6 months

Secondary Outcomes (15)

• Aided Thresholds Fusion-unaided

  6 months

• Aided Thresholds Fusion PTA4

  Baseline, 1 and 6 month(s)

• Aided Thresholds Fusion

  Baseline, 1 and 6 month(s)

• Aided Thresholds Fusion-BCI PTA4

  6 months

• Aided Thresholds Fusion-BCI

  6 months

Study Arms (1)

Fusion sound processor

EXPERIMENTAL

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: Fusion Sound Processor

Interventions

Fusion Sound Processor DEVICE

Sound Processor

Fusion sound processor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects implanted with the Bridging Bone Conductor (BBC) implant
• Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
• Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
• Active user of the BCI SP

You may not qualify if:

• Inability to participate in follow-ups
• Unsuitable as judged by the principle investigator or the sub-investigator

Sponsors & Collaborators

• Oticon Medical: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

ENT departement, Sahlgrenska University Hospital

Gothenburg, 413 46, Sweden

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Oticon Medical

studyinfo@oticonmedical.com

0046-31-7486100

Study Officials

• Måns Eeg Olofsson, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 15, 2017
• Study Start: November 15, 2017
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: March 17, 2025
• Results First Posted: December 9, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)