Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

NCT03780374 | Completed

• 1 other identifier: Sonova2018_37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech Intelligibility in Noise

  The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold).

  4 weeks

Secondary Outcomes (9)

• Sound Quality - Overall

  16 weeks

• Loudness - Laboratory

  8 weeks

• Loudness - Daily Life

  16 weeks

• Clarity - Daily Life

  16 weeks

• Preferred Sound Processing Principle

  16 weeks

Study Arms (3)

Sound Processing Principle 1

ACTIVE COMPARATOR

Sound Processing Principle 1 will be applied in the hearing aid.

Device: Phonak Audéo L2M with Sound Processing Principle 1

Sound Processing Principle 2

EXPERIMENTAL

Sound Processing Principle 2 will be applied in the hearing aid.

Device: Phonak Audéo L2M with Sound Processing Principle 2

Sound Processing Principle 3

EXPERIMENTAL

Sound Processing Principle 3 will be applied in the hearing aid.

Device: Phonak Audéo L2M with Sound Processing Principle 3

Interventions

Phonak Audéo L2M with Sound Processing Principle 1 DEVICE

Compensation of a hearing loss with Sound Processing Principle 1.

Sound Processing Principle 1

Phonak Audéo L2M with Sound Processing Principle 2 DEVICE

Compensation of a hearing loss with Sound Processing Principle 2.

Sound Processing Principle 2

Phonak Audéo L2M with Sound Processing Principle 3 DEVICE

Compensation of a hearing loss with Sound Processing Principle 3.

Sound Processing Principle 3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature

You may not qualify if:

• Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
• Limited mobility and not in the position to attend weekly appointments
• Limited ability to describe listening impressions/experiences and the use of the hearing aid
• Inability to produce a reliable hearing test result
• Massively limited dexterity
• Known psychological problems
• Known central hearing disorders

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant's will not know which intervention will be applied.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 19, 2018
• Study Start: December 3, 2018
• Primary Completion: January 15, 2019
• Study Completion: March 15, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Locations

CH (1)