Clinical Performance of a New Implant System for Bone Conduction Hearing

NCT03086135 | Completed Results FDA Device

• 1 other identifier: CBAS5539
• Study Type: interventional
• Target: 51
• Locations: 5 countries
• Sites: 5

Brief Summary

To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.

Conditions

Deafness; Sensoneural Single Sided; Conductive Hearing Loss; Mixed Hearing Loss

Outcome Measures

Primary Outcomes (2)

• Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months

  The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.

  Baseline before surgery, 3 months after surgery

• Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.

  The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.

  Baseline before surgery, 3 months after surgery

Secondary Outcomes (22)

• Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months

  Baseline before surgery, 4 weeks, 6 and 12 months after surgery

• Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months

  Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.

• Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months

  Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.

• Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months

  Baseline before surgery, 4 weeks, 6 and 12 months after surgery

• Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months

  Baseline before surgery, 3 and 12 months after surgery

Study Arms (1)

Bone-conduction hearing device

EXPERIMENTAL

The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet.

Device: Osia System

Interventions

Osia System DEVICE

An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.

Bone-conduction hearing device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (18 years or older)
• Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.
• OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
• Signed informed consent
• Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)

You may not qualify if:

• Uncontrolled diabetes as judged by the investigator.
• Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
• Insufficient bone quality and quantity for implantation of a BI300 Implant.
• Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
• Unable to follow investigational procedures, e.g. to complete quality of life scales.
• Participation in another clinical investigation with pharmaceutical and/or device.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (5)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, VIC 3002, Australia

Location

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

World Hearing Center Institute of Physiology and Pathology of Hearing

Kajetany, Nadarzyn, 05-830, Poland

Location

MeSH Terms

Conditions

Deafness; 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: Professor Emmanuel Mylanus
• Organization: Radboud University Medical center, Nijmegen

Emmanuel.Mylanus@radboudumc.nl

+31 24 361 49 34

Study Officials

• Emmanuel Mylanus, Prof.

  Radboud Univerity Medical centre

  PRINCIPAL INVESTIGATOR

• Robert Briggs, Prof.

  The Royal Victorian Eye and Ear Hospita

  PRINCIPAL INVESTIGATOR

• Susan Arndt, Prof.

  Universitätsklinikum Freiburg

  PRINCIPAL INVESTIGATOR

• Piotr Skarżyński, Ass.Prof.

  Center of Hearing and Speech

  PRINCIPAL INVESTIGATOR

• Henry Alexander Arts, Prof.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 22, 2017
• Study Start: March 9, 2017
• Primary Completion: October 30, 2018
• Study Completion: June 20, 2019
• Last Updated: October 14, 2021
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); NL (1); DE (1); PL (1); AU (1)