Evaluation of Sound Processor for a Transcutaneous System

Conductive Hearing Loss Clinical Trial

Official title:

Single Center Evaluation of a Sound Processor for a Transcutaneous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374787
• Other study ID #: C58
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: November 22, 2018

Study information

• Verified date: April 2019
• 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 speech intelligibility 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: Completed
• Enrollment: 10
• Est. completion date: November 22, 2018
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Inability to participate in follow-ups

• Unsuitable as judged by the principle investigator or the sub-investigator

Related Conditions & MeSH terms

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

Intervention

Device:
• Fusion Sound Processor
Sound Processor

Locations

Country	Name	City	State
Sweden	ENT departement, Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Oticon Medical	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aided thresholds Fusion-unaided PTA	Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)	6 months
Secondary	Aided thresholds Fusion-unaided	Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz	6 months
Secondary	Aided thresholds Fusion PTA4	Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)	Baseline, 1 and 6 month(s)
Secondary	Aided thresholds Fusion	Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at	Baseline, 1 and 6 month(s)
Secondary	Aided thresholds Fusion-BCI PTA4	Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)	6 months
Secondary	Aided thresholds Fusion-BCI	Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz	6 months
Secondary	Speech intelligibility Fusion-unaided %	Difference between Fusion-aided and unaided speech intelligibility scores (in % correct)	6 months
Secondary	Speech intelligibility Fusion-unaided signal to noise ratio (SNR)	Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR	6 months
Secondary	Speech intelligibility Fusion %	Difference between Fusion-aided speech intelligibility scores (in % correct)	Baseline, 1 and 6 month(s)
Secondary	Speech intelligibility Fusion SNR	Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR	Baseline, 1 and 6 month(s)
Secondary	Speech intelligibility Fusion-BCI %	Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct)	6 months
Secondary	Speech intelligibility Fusion-BCI SNR	Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR	6 months
Secondary	Magnet strength	Difference in magnet strength measured on the patient's heads in Newton	Baseline, 1 and 6 month(s)
Secondary	IPS (Inflammation, Pain, Skin height/numbness) evaluation	Combined score of IPS evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales)	Baseline, 1 and 6 month(s)
Secondary	Subjective evaluation	User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor	Baseline, 1 and 6 month(s)
Secondary	Subjective evaluation SSQ	Subjective performance as measured by Speech, Spatial and Quality (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect"	Baseline, 1 and 6 month(s)