None listed
Conditions
Brief summary
Kanso sound processor is not currently approved for use in mainland China. This study is to test the performance of Kanso using speech testing procedures with native Mandarin speech test materials. Performance will be compared with the currently approved CP910/CP920 sound processor.
Interventions
The purpose of the investigation is to collect data regarding native mandarin language speech perception with the Kanso sound processor compared with the currently available CP10/CP20 sound processor.
Study participants will attend for a single session of one-on-one, face-to-face, sound booth testing using both the Kanso (off-the-ear (OTE) sound processor) and the CP910/CP920 (previous generation behind-the-ear (BTE) sound processor).
Testing will be performed by an audiologist and involve sp
The purpose of the investigation is to collect data regarding native mandarin language speech perception with the Kanso sound processor compared with the currently available CP10/CP20 sound processor. Study participants will attend for a single session of one-on-one, face-to-face, sound booth testing using both the Kanso (off-the-ear (OTE) sound processor) and the CP910/CP920 (previous generation behind-the-ear (BTE) sound processor). Testing will be performed by an audiologist and involve speech perception testing in quite and in noise. The order of testing (i.e. Kanso or CP910/CP920 first) will vary between participants by random assignment, but all participants will be required to complete the tests with both the test device and the comparator device. Individual tests may take about 20 minutes to complete. The total time for all tests is expected to be 2 hours, allowing for up to 20 minutes between treatment arms. After completing all eligibility and baseline assessments the participants will undergo all tests within a single visit, as described above. An additional visit may be scheduled if the participant is unable to complete all the required tests in one session.
Sponsors
Cochlear
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eighteen years of age or older 2. At least 6 months experience with a Cochlear Nucleus 24 series (CI24M, CI24R(CA), CI24R(ST)), Freedom series (CI24RE (CA), CI24RE (ST), CI422) or CI500 series implant (CI512, CI522) 3. At least 6 months experience with one of the following Sound Processors: CP802, CP810, CP920 or CP910 sound processor 4. Native Mandarin language 5. Signed informed consent 6. Willingness to participate in and to comply with all requirements of the protocol 7. Normal cochlea anatomy bilaterally before implantation 8. Stable MAP for 6 months prior to enrolment 9. Baseline speech in quiet score (>30% syllable recognition rate using the HOPE test)
Exclusion criteria
1. Subjects who are unable to follow investigational procedures 2. Bipolar, dual electrode or double electrode MAPs 3. Less than 16 hours battery life with current sound processor MAP 4. Concurrent participation is another investigation with pharmaceuticals or medical device 5. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 6. Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study 7. Individuals with lack or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, subjects in emergency situations, homeless persons, and those incapable of giving informed consent 8. Members of a group with a hierarchical structure such as employees of a subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention 9. Patients who wear or have implantable life support devices such as pacemakers and implantable cardioverter defibrillators 10. Pregnant and lactating patients
Outcome results
None listed