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Evaluation of the effect of Cochlear Sound Processor upgrade (N6/N7 to N8)

Evaluation of the effect of Cochlear Sound Processor upgrade (N6/N7 to N8)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036303
Enrollment
250
Registered
2025-04-02
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z96.2

Interventions

Group 1: Upgrade to the N8 speech processor (before and after observation) - Upgrade takes place at the second of three appointments - Trial for 30+/-7 days, testing at the third appointment - N8 spe

Sponsors

Cochlear Deutschland GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - CI from the manufacturer Cochlear with a speech processor from the CP900 or CP1000 series (one or both sides) - at least 5 years of hearing experience in the ear that is to be upgraded - must be able to understand the purpose and risks of the study and provide signed and dated informed consent - must be able to comply with study-related tests and procedures - must speak German at an appropriate level so that the questionnaires can be answered independently

Exclusion criteria

Exclusion criteria: - in addition to the hearing impairment, no other disability, neurological disease or cognitive impairment that could have an influence on the course of the study or that would make the survey (app) too physically or mentally demanding - Simultaneous participation in other studies that may overburden the test person or influence the study results

Design outcomes

Primary

MeasureTime frame
Achieved effects (effectiveness) - with regard to a possible improvement in communication skills or a reduction in listening effort in noisy situations. Target parameters: 1) Single-syllable comprehension in quiet 2) Speech comprehension in noise with spatial separation of speech and noise source 3) Listening effort in noise with spatial separation of speech and noise source

Secondary

MeasureTime frame
With the help of an app (HearDL app) on study smartphones, Ecological Momentary Assessment (EMA) and questionnaires, query of satisfaction in everyday life, as well as health-related quality of life with regard to a possible hearing-related improvement in everyday life Target parameters (Patient Response Outcome (PRO) tools): 1) Hearing ability in everyday situations (questionnaire SSQ12) 2) Gain from hearing system fitting (APHAB questionnaire) 3) Self-perceived hearing impairment (RHHI-S questionnaire) 4) Further context-dependent questions Sound, clarity, loudness of speech (EMA) Using data logging data from the manufacturer's fitting software: Frequency and type of use Target parameters: 1) Which programs are used 2) Frequency and duration of program use 3) Switching frequency 4) Switching time

Countries

Germany

Contacts

Public ContactMelanie Zokoll

Hörzentrum Oldenburg gGmbH

zokoll@hz-ol.de04412172164

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026