Characterisation of intra- and post-operative Neural Response Telemetry (NRT) recording parameters in Nexa cochlear implants

ISRCTN	ISRCTN16238525
DOI	https://doi.org/10.1186/ISRCTN16238525
Sponsor	Cochlear
Funder	Cochlear

Submission date: 21/05/2026
Registration date: 16/06/2026
Last edited: 29/06/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

PRS Specialist
Public

1 University Avenue
Macquarie University
Sydney
2109
Australia

Phone	+61 2 9428 6555
Email	cltd-prs-admin@cochlear.com

Prof Andrzej Zarowski
Scientific, Principal investigator

Oosterveldlaan 24
Wilrijk (Antwerp)
2610
Belgium

Phone	+3232906000
Email	andrzej.zarowski@zas.be

Anke Plasmans
Scientific, Principal investigator

Schaliënhoevedreef 20, Building i
Mechelen
2800
Belgium

Phone	+32 15 79 55 11
Email	aplasmans@cochlear.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Basic science
Scientific title	Prospective within-subject exploratory study of intra-operative and post-operative NRT recordings using varying parameters in Nucleus® Nexa™ cochlear implant recipients
Study acronym	NERT
Study objectives	This characterisation study is designed to compare Electrically Evoked Compound Action Potential (ECAP) recordings within participants using different sets of Neural Response Telemetry (NRT) recording parameters implemented in the Cochlear™ Objective Measures (COM) software.
Ethics approval(s)	Submitted 24/04/2026, Hospital aan de Stroom (ZAS) – Committee on Medical Ethics (Commissie Medische Ethiek) (CME) (Oosterveldlaan 24, Wilrijk (Antwerp), 2610, Belgium; +32 3 443 38 62; gza.ec@zas.be), ref: RL2026-608
Health condition(s) or problem(s) studied	Evaluate ECAP recordings obtained using different NRT recording parameter configurations for participants already implanted with a Nexa cochlear implant or candidates for this implant.
Intervention	Adult Nexa™ implant users will undergo one research session accompanying a standard clinic visit or surgery. During this session, ECAP recordings will be performed with different NRT recording parameter settings in the COM software. In this study, COM is used during surgery and in clinic visits to support objective assessment of impedances, Trans Impedance Matrix (TIM), and NRT responses in Cochlear implant users and to provide a reference standard for evaluating the quality of ECAP recordings obtained during the investigation. The study includes randomisation of different parameter settings to be used. Participants will be assigned to their randomisation order based on the sequence of inclusion. Randomisation will follow a predefined randomisation schedule generated prior to study start. The schedule will be produced using a validated computer-based method to ensure allocation concealment and to minimise selection bias.
Intervention type	Other
Primary outcome measure(s)	Within-subject repeated measurements of clinical impedances, measured using impedance values before vs. after conditioning, and postoperatively using the COM software at Visit 1 (intraoperative and postoperative) Within-subject repeated measurements of NRT, measured using NRT thresholds before vs. after conditioning, and postoperatively across NRT configurations, using the COM software at Visit 1 (intraoperative and postoperative)
Key secondary outcome measure(s)
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Implanted with a Nucleus CI1032/CI1022/CI1024/CI1012 or scheduled for Nucleus CI1032/CI1022/CI1024/CI1012 implantation 2. 18 years or older (no upper age limit) 3. Sufficient speaker of Dutch to communicate with the investigator and correctly understand the informed consent form, as judged by the investigator 4. Willing to participate and comply with all requirements of the study protocol 5. Willing and able to provide written informed consent
Key exclusion criteria	1. Diagnosis of auditory neuropathy 2. Additional health factors, known to the investigator, that would prevent or limit participation in the study 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 this investigation 6. Pregnant or breastfeeding women, as reported by the participant 7. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation)
Date of first enrolment	07/06/2026
Date of final enrolment	31/12/2026

Locations

Countries of recruitment

Belgium

Study participating centres

European Institute for Otorhinolaryngology (EIORL) – Sint Augustinus Antwerp (ENT Department)

Oosterveldlaan 24
Wilrijk
Antwerp
2610
Belgium

Cochlear Technology Centre Belgium

Schaliënhoevedreef 20
Mechelen
B 2800
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

29/06/2026: Study participating centres added.
27/05/2026: Study’s existence confirmed by the Hospital aan de Stroom (ZAS) Committee on Medical Ethics (CME), Belgium.