Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO

NCT06700512 | Completed Results

• 1 other identifier: D00325215
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities

Conditions

Hearing Loss, Sensorineural

Keywords

Hearing aid; Freiburger; Matrix Test; SSQ; IOI-HA

Outcome Measures

Primary Outcomes (1)

• Oldenburg Sentence Test

  The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.

  Estimated Time Frame 2 weeks (Test conducted at second lab session).

Secondary Outcomes (5)

• Freiburger Monosyllabic Speech Test

  Estimated Time Frame 2 weeks (Test conducted at second lab session).

• Match-to-Target

  1 day (Fitting procedure with real-ear measurements is done at first lab session)

• Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)

  2 weeks

• International Outcome Inventory for Hearing Aids (IOI-HA)

  2 weeks

• Satisfaction Questionnaire

  2 weeks

Study Arms (1)

Evaluation of Study Device followed by Own devices

EXPERIMENTAL

within subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care.

Device: Hearing Aid Signia Pure C&G 7IX; Device: Own Hearing Aid

Interventions

Hearing Aid Signia Pure C&G 7IX DEVICE

Receiver in Canal (RIC) hearing aid, M Receiver

Evaluation of Study Device followed by Own devices

Own Hearing Aid DEVICE

subjects' own hearing aids, any brand, any model

Evaluation of Study Device followed by Own devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hearing loss should fall within fitting range of study hearing aid
• They should be experienced hearing aid users
• Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
• Sensorineural HL, mild-to-moderate
• HL corresponding to the fitting range of the hearing aid
• Healthy (outer) ear
• Older than 18 years
• German is mother tongue
• Able to understand the instructions
• Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
• Informed consent

You may not qualify if:

• Contraindication for hearing aid treatment
• Fluctuating or rapidly progressing hearing loss
• "Central" hearing problems
• Limited mobility
• Limited dexterity (in handling the hearing aid)
• Known psychological problems

Sponsors & Collaborators

• WSAUD A/S: lead

Study Sites (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, 26129, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Veronika Littmann
• Organization: WSAUDAS

Veronika.littmann@wsa.com

+4991313080

Study Officials

• Matthias Vormann, PhD

  Hörzentrum Oldenburg gGmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: June 14, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 26, 2024
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)