Clinical Evidence & Product Validation
Evidence that stands up to scrutiny
From electroacoustic benchmarking to clinical study design and coordination, we help you generate the right evidence at the right stage — and present it in a way buyers, audiologists and regulators understand.
Clinical and validation services
Acoustic and electroacoustic benchmarking
Output, frequency response, distortion, noise and feedback measured against relevant standards and competitors.
Speech intelligibility testing
Objective speech intelligibility and SNR improvement in noise, using an acoustic manikin.
Hearing-aid performance evaluation
Systematic evaluation of processing modes, directionality, noise reduction and latency.
Clinical study design and coordination
Population, endpoints and protocol defined, with qualified research sites coordinated.
Real-world usability studies
Ease of use, comfort and user experience in real settings.
Care-home communication technology evaluation
Suitability of assistive communication technology in residential care.
Independent product performance reporting
Transparent, reproducible test conditions, methods and results.
Research white papers
Evidence summaries for buyers and professionals.
Scientific manuscript preparation and publication support
Data preparation and drafting support. Publication is decided by journal peer review.
Evidence planning for UK/EU requirements
Claims-to-evidence mapping and gap analysis for your regulatory team.
Clinical evidence and research
Four kinds of evidence, each with a different purpose
Select an evidence type to see the question it answers and who is responsible.
“How does the product perform under controlled conditions?”
Objective laboratory measurement of electroacoustic performance, speech intelligibility metrics and more.
Tingli can run or coordinate this independently.
“Can users use the product easily and comfortably?”
Ease of use, comfort and user experience in real or simulated settings.
Tingli designs and coordinates, under appropriate ethics and consent arrangements.
“Is the product safe and effective in the target population?”
Medical-device clinical investigation under applicable regulations and standards (e.g. ISO 14155), requiring ethics approval and, in some cases, notification to the competent authority.
Tingli supports design and coordination; qualified sites and investigators conduct it.
“Can the product be legally placed on the market?”
Conformity assessment and registration by a Notified Body, UK Approved Body or authority such as the FDA.
Your regulatory team and the relevant bodies. Tingli supports evidence planning and guarantees no outcome.
Across the product lifecycle
Three phases across the product lifecycle
Select a phase to see what we do and what you receive.
Phase 1 · Before CE / UKCA marking or FDA submission
Can the product's performance be shown objectively — and is it comfortable and usable for real listeners?
What we do
- Electroacoustic measurement against relevant standards (e.g. IEC 60118, ANSI S3.22)
- Objective speech intelligibility and signal-to-noise improvement in noise, using an acoustic manikin
- Processing latency, acoustic feedback stability and repeatability
- Audiologist-led feasibility and comfort assessment
- Structured initial feedback from a limited group of users
You receive
- Objective measurement report
- Feasibility and comfort findings
- Prioritised engineering actions
Decision it informs: Whether the product is ready for regulatory submission and a clinical study.
Phase 2 · After CE marking
Can you show, with evidence, that the product helps users — and present it convincingly to the market?
What we do
- Design and coordination of a clinical evaluation study with real users
- Analysis of outcomes such as speech understanding in noise and user-reported benefit
- White paper summarising the evidence
- Photography and video of the product in use
- Buyer and channel insight for the UK and European markets
You receive
- Clinical evidence report
- White paper
- Photo and video assets
- Market-entry plan
Decision it informs: How to launch, and which channels to prioritise.
Phase 3 · On the market
What should the next version improve, and how will you know it is better?
What we do
- Collection and analysis of real-world user feedback
- Benchmarking the new version against the previous one
- Prioritised improvement roadmap for R&D
- Repeat objective measurement to confirm improvements
You receive
- User feedback analysis
- Benchmark report
- Improvement roadmap
Decision it informs: What to change in the next generation.
Together, phases 1 and 2 — objective data before registration and clinical evidence after it — give your product a complete, credible evidence base. That combination is the unique help we offer.
Regulatory strategy and registration decisions (CE, UKCA or FDA) remain with your regulatory team and the relevant bodies. Tingli provides measurement and evidence support and does not guarantee certification. Testing with users runs under the appropriate ethical approvals and informed consent, and results are reported as found.
Deliverables
- Objective measurement and benchmark reports
- Study protocol and ethics-application support
- Clinical evidence report
- Research white paper
- Photo and video of the product in use
- Manuscript drafts
Any third-party engagement, facility use and participant testing are subject to the applicable arrangements and approvals. Tingli does not promise regulatory approval, favourable results or journal publication; results are reported as found.
Let's discuss your product
Tell us about your product, target market and the decision you need to make. We work in English or Mandarin, and everything you share is kept confidential.