Contract research
Individual study solutions for your audiological products
As a full-service contract research organization (CRO), we work with our partners to offer you customized audiological studies for hearing aids, cochlear implants, over-the-counter devices, and other hearing solutions.
With 30 years of combined experience
An Overview of Our Services
From planning to evaluation
We coordinate your single-center or multi-center studies and assist you in preparing your study documentation—from the study protocol and ethics application to the informed consent forms for participants. In addition, we advise you on selecting appropriate measurement methods to ensure maximum statistical power.
Program Formats & Regulatory Services
We offer the following services for hearing aids, cochlear implants, over-the-counter hearing aids, and other hearing solutions:
- Preclinical and clinical studies and observational studies on hearing aids with and without CE marking
- Conducting clinical trials as a trial site in accordance with MDR 2017/745, the Medical Devices Act (MPDG), ISO 14155, and GCP
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) Studies & Compliance Assessments
- Claim Studies/Scientific Marketing
- Formative and summative usability tests in accordance with MDR and IEC 62366 (Usability Documentation)
- Consulting, documentation, guidelines for study designs, e.g., studies in accordance with MDR
- Biometrics/Power Analysis
- (External) Study monitoring of clinical trials in accordance with the MDR
- Preparation of (coordinated) ethics applications as part of individual ethics applications and existing umbrella ethics applications submitted to the Oldenburg Medical Ethics Committee
- Reports and publications (peer-reviewed) and support/development of white papers
Phases based on ISO 14155
Without the CE mark – exploratory
Without the CE mark – clinical
CE marked – clinical
CE marked – for observation
Testing center with more than 2,000 active participants
A key advantage: our own database of clinical trial participants, which includes more than 2,000 volunteers. Whether young or old, with normal hearing or hearing loss, fitted with hearing aids or not—our database allows us to specifically recruit participants who are suitable for any research question. This enables us to conduct your studies in a targeted manner.
The total number of participants is currently N=2,293 (50% female), broken down by age decade. Hearing loss categories were classified according to PTA4 (0.5, 1.0, 2.0, and 4.0 kHz) for the better ear in dB HL (2021 WHO classification).
Recruiting participants is one of our ongoing tasks to ensure that our pool of candidates remains high-quality and up-to-date.
Technological & methodological diversity
As a developer of innovative measurement methods, we offer you study designs that realistically depict listening and communication situations. These include
- Speech tests with realistic signal-to-noise ratios
- Dual-task setups
- audiovisual scenarios
- Measurements on listening effort & fatigue
- EMA approaches (ecological momentary assessment)
- Usability tests
For mobile applications, we rely on our self-developed "Portable Hearing Lab" - a research hearing aid in smartphone format. In combination with our suitcase studies as no-touch studies, this enables us to conduct studies completely remotely.
Let us advise you without obligation!
Whether you have an initial idea or a specific study plan - feel free to contact us!
In a free initial consultation, we will show you which options are suitable for your issue and what a collaboration could look like.
