Trial Outcomes & Findings for Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs (NCT NCT02156167)

Results Overview

The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions. Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

3 months after initial upgraded fitting

Results posted on

2016-07-21

Participant Flow

Center contacted their patients, who received a Codacs device in another clinical trial by phone in October 2013

Participant milestones

Participant milestones
Measure	CP810 Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP810 n=15 Participants Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants
Age, Continuous	66 years n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment Germany	15 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months after initial upgraded fitting

Population: One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness

The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions. Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810).

Outcome measures

Outcome measures
Measure	CP810 n=13 Participants Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N0 - E - Freedom	-0.83 dB SNR Standard Deviation 2.04
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N0 - E - CP810	-1.45 dB SNR Standard Deviation 2.29
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N90 - E - Freedom	0.64 dB SNR Standard Deviation 2.92
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N90 - E - CP810	0.89 dB SNR Standard Deviation 2.83
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N0 - N - CP810	-1.22 dB SNR Standard Deviation 1.69
Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test S0N90 - N - CP810	-3.78 dB SNR Standard Deviation 3.33

Adverse Events

CP810

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christiane D'hondt, Clinical Research Specialist

Cochlear

Phone: +32 15 76 55 14

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60