A study comparing speech perception of off-the-ear and behind-the-ear sound processors in adults with hearing loss

Not Applicable

Completed

• Conditions: Post lingual deafness; Ear - Deafness

• Registration Number: ACTRN12619000992101
• Lead Sponsor: Cochlear

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-12
• Study Completion: 2020-01-19
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified