CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

Hearing Impairment, Sensorineural Clinical Trial

Official title:

A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286385
• Other study ID #: CLTD5818
• Status: Completed
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: June 29, 2022

Study information

• Verified date: July 2022
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.

Description:

This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 29, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older

2. Post lingually deafened

3. Implanted with the CI600 Series, CI500 Series or Freedom Series

4. At least 6 months experience with a cochlear implant.

5. At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor

6. MAP Total Stimulation Rate of 7.2kHz or greater

7. Able to score 30% or more with CI alone on a monosyllabic words in quiet test

8. Willingness to participate in and to comply with all requirements of the protocol

9. Fluent speaker in English as determined by the investigator

10. Willing and able to provide written informed consent

Exclusion Criteria:

1. Additional disabilities that would prevent participation in evaluations.

2. Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.

3. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the Investigator.

4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.

5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.

6. Currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

7. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment, Sensorineural
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• CP1150 Sound Processor
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
• CP1150 (modified firmware)
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware.
• CP1150 + FF
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
• CP1110
Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.

Locations

Country	Name	City	State
Australia	Cochlear Sydney	Macquarie Park	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cochlear	Avania

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech perception in quiet using an OTE Sound Processor	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.	One day
Secondary	Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF	One day
Secondary	Speech perception in quiet with CP1150 and CP1110 Sound Processors	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor	One day